Use caution Medical device recall · FDA · Published July 15, 2024
Alcon ClearCut SB Intrepid 2.2 ANG Ophthalmic Knives: Sharpness Risk
Alcon recalls specific ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to increased reports of sharpness issues. Affected models include catalog number 8065992561. Consumers should check their product details.
Use caution until it’s fixed
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Contact the company
Recalling firmAlcon Research LLCAspex Facility, 6201 South Fwy · Fort Worth, TX 76134-2099
What happened, in plain English
Alcon is recalling specific ClearCut SB Intrepid 2.2 ANG ophthalmic knives because they have been reported to be too sharp. This could cause injury during use by eye care professionals. Read more at govinfonow.com/recall/54613-alcon-clearcut-sb-intrepid-2-2-ang-ophthalmic-knives-sharpness.
Source Summary by GovInfoNow · govinfonow.com/recall/54613-alcon-clearcut-sb-intrepid-2-2-ang-ophthalmic-knives-sharpness · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2664-2024
Cite this page
“Alcon ClearCut SB Intrepid 2.2 ANG Ophthalmic Knives: Sharpness Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54613-alcon-clearcut-sb-intrepid-2-2-ang-ophthalmic-knives-sharpness. Based on FDA recall #Z-2664-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2664-2024%22&limit=1).
Why it’s dangerous
The knives have been reported to be too sharp, which could lead to injury during eye surgery procedures. This sharpness issue is a safety concern for medical professionals using the tools.
Who’s affected
Eye care professionals who use the ClearCut SB Intrepid 2.2 ANG ophthalmic knives are most at risk. The recall affects specific models sold with catalog number 8065992561.
How to tell if you have this one
Check for the model number 8065992561 on the product. The recall applies to ophthalmic knives sold with this specific catalog number.
- Brand
Alcon- Category
Medical device
All 36 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2645-2024 | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065771540; UDI-DI: 00380657715404; Lot numbers: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, 16DDRU | 20,034 units |
| Z-2646-2024 | Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A; Model/Catalog Number: 8065751658; UDI-DI: 00380657516582; Lot Numbers: 16C4MR, 16K84T, 16FXTD. | 3,721 units |
| Z-2647-2024 | Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A; Model/Catalog Number: 8065830077; UDI-DI: 380658300777; Lot numbers: 16A6HT, 16A6HU, 16A6HV, 16FX1Y, 16FX20, 16FE93, 16HE6Y, 16HE70, 16HYEN, 16HYEP. | 8,701 units |
| Z-2648-2024 | Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. 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C29050-02, C29053-02, C29067-02, C29073-05, C29074-04, C29075-01, C29076-01, C29080-03, C29084-01, C29085-03, C29088-01, C29089-04, C29093-03, C29097-02, C29098-02, C29114-03, C29116-02, C29117-02, C29124-02, C29126-01, C29130-02, C29134-02, C29136-02, C29143-02, C29152-01, C29153-02, C29160-04, C29161-03, C29162-02, C29166-01, C29169-02, C29170-02, C29171-01, C29175-01, C29176-01, C29184-02, C29187-01, C29189-02, C29190-01, C29192-03, C29197-01, C29205-01, C29206-01, C29206-02, C29208-01, C29209-02, C29213-01, C29217-02, C29223-02, C29224-03, C29225-01, C29225-02, C29232-01, C29235-01, C29242-01, C29251-01, C29254-01, C29260-01, C29261-01, C29262-01, C29262-02, C29265-01, C29270-01, C29273-01, C29275-01, C29275-02, C29276-01, C29290-01, C29295-01, C29304-01, C29305-01, C29313-01, C29315-01, C29323-02, C29331-02, C29332-02, C29333-01, C29334-01, C29339-01, C29342-01, C29346-01, C29347-01, C29349-01, C29352-02, C29355-02, C29368-01, C29375-03, C29381-01, C29382-01, C29383-01, C29384-01, C29387-01, C29398-01, C29411-02, C29433-01, Q29139-01, Q29159-01, Q29188-01, Q29195-01, Q29237-01, Q29258-01, QNS29155-01, QNS29189-01, QNS29216-01, QNS29232-01, QNS29236-01, QNS29247-01; Lot numbers: 165FKV, 165DRJ, 165YN0, 165Y8W, 165YA5, 165YPJ, 1667A5, 166798, 1668VE, 166EDM, 166EDF, 166C7D, 166H41, 166MY2, 166N03, 166N0Y, 166PNU, 166PM7, 166PMR, 166PNW, 166PMU, 166PPA, 166PP1, 166PPC, 166PN0, 166PNM, 166V8P, 166V7J, 166V6W, 166VR2, 166V6M, 166YH3, 16734T, 16719J, 166YKD, 166YHM, 16716R, 1673RW, 16765V, 1677HD, 1674D0, 1673PM, 1673U5, 1677CM, 1673P9, 1673NX, 1673PD, 1673R8, 1673RC, 1673PH, 16744C, 16745K, 1677DN, 167469, 1674CY, 16775Y, 167738, 1677E8, 167876, 167849, 167874, 16787W, 167EF7, 167E1N, 167DYT, 167ART, 167ARD, 167AC2, 167F4X, 167HN8, 167JX7, 167JVX, 167JVC, 167JVD, 167JWA, 167JV3, 167JVM, 167LND, 167MN9, 167MNL, 167R0M, 167R1W, 167MNH, 167UF5, 167UHC, 167UF7, 167TAT, 167UM6, 167VJK, 167VJ9, 167TJ4, 167THF, 167TF5, 167TF7, 167TA0, 167UMA, 167V1N, 167TFR, 167TKU, 167UKX, 167UFX, 167UFP, 167TAX, 167UH4, 167TC1, 167UK1, 167V2F, 167XYL, 167YFJ, 167XAF, 167XAL, 167YFE, 167YFP, 167XAM, 167W1H, 167W18, 167W22, 167VY6, 167VXC, 167W5E, 167W1W, 167VYK, 167VXX, 167XCN, 167VXR, 168077, 1681F7, 1681HA, 167YW8, 168099, 16803H, 167YY8, 1681HT, 167YX6, 167YY9, 168282, 16828U, 16828T, 1682PP, 1682NP, 1682R2, 1682R0, 1682T9, 1682TD, 1682TT, 1682NF, 1682P7, 1683W0, 1683W1, 1683W2, 1686E9, 168571, 16864J, 16858H, 1686EN, 16855L, 16856U, 16858C, 16863P, 16858J, 168555, 1687ND, 168993, 1687JV, 1687K2, 1687XT, 1688MR, 1687UW, 1688N9, 1689T5, 1689T0, 1689R0, 168AWR, 1689KV, 1689LM, 1689KD, 1689JT, 1689JV, 1689TE, 1689RM, 1689TL, 1689P3, 168CU8, 168CUP, 168E53, 168E4U, 168CU2, 168CUR, 168CWP, 168CW7, 168E4C, 168E4H, 168E4J, 168E60, 168E5T, 168DEL, 168DEM, 168E5C, 168D9Y, 168E5K, 168EJ0, 168EJP, 168EHR, 168EJV, 168EK8, 168EJE, 168EKH, 168F4M, 168F64, 168F51, 168F61, 168F6U, 168F54, 168F5K, 168F5E, 168J08, 168J15, 168J0W, 168J13, 168J1U, 168J0U, 168JDN, 168JCW, 168LL4, 168LLM, 168LDX, 168KC9, 168K4X, 168K5Y, 168LD1, 168LCJ, 168LEW, 168LCK, 168LAX, 168LD9, 168LD4, 168LDD, 168LCM, 168LK6, 168KJ7, 168LD6, 168LH5, 168K52, 168KE5, 168KAU, 168LF0, 168KDK, 168KAP, 168LMD, 168NH1, 168NEU, 168NPN, 168NHM, 168NVV, 168M8N, 168NTN, 168M5W, 168M91, 168M3A, 168M3K, 168M5M, 168M79, 168M8R, 168PXC, 168UA6, 168U1N, 168U2W, 168U2Y, 168R7K, 168R85, 168UXF, 168U1T, 168U2N, 168VJT, 168VKM, 168VJR, 168VKP, 168VK9, 168VK5, 168VPH, 168VTR, 168VPY, 168VKF, 168VKW, 168VL9, 168VLA, 168VL2, 168VJD, 168VLC, 168VKX, 168VK0, 168VJF, 168VKY, 168VJU, 168VLD, 168VJV, 168VKH, 168VJJ, 168VKJ, 168WV8, 168WV9, 168X5M, 168X5F, 168XEH, 16902C, 16900J, 16902F, 169002, 16902A, 16916C, 1692PM, 169155, 16918J, 1692PL, 16915L, 1691M1, 1692CR, 1692CY, 1692N7, 1692AT, 16918W, 1691A5, 1692C1, 1692MC, 1694R1, 16950L, 1693RA, 1693LC, 1693LK, 1694TA, 1693UR, 1694P6, 16951Y, 1697JF, 1697HA, 1696DT, 1697JH, 16963V, 1696AM, 1697FT, 1697H8, 169601, 1697J9, 1697JC, 1696A9, 1697FR, 1695YW, 1697HN, 169604, 1698A1, 1698K9, 1699K5, 1698A0, 1698KX, 1698KL, 16988K, 169877, 1698L2, 169A10, 169A24, 169A2L, 169ADT, 169AE6, 169AH4, 169AF0, 169E0W, 169D23, 169D22, 169D2L, 169D27, 169CK1, 169CH9, 169CHU, 169CHT, 169F7X, 169FE9, 169E8X, 169E90, 169F79, 169F7A, 169E2X, 169F6C, 169E63, 169E3C, 169F6F, 169F6H, 169F7C, 169E6V, 169J3W, 169J34, 169J3X, 169J54, 169J5X, 169J6M, 169J6C, 169K3V, 169K60, 169J48, 169K45, 169J5T, 169J8E, 169K4V, 169KTM, 169M5D, 169M6A, 169M6C, 169M74, 169M1R, 169NL1, 169NJ8, 169M4U, 169NJ3, 169NJ6, 169M1A, 169NJ4, 169R8F, 169NLD, 169RPR, 169R89, 169RXR, 169RY6, 169TX0, 169TWT, 169T1C, 169T10, 169TXF, 169T4H, 169T3C, 169RXL, 169RYU, 169TW8, 169TW0, 169RYV, 169TVX, 169T3P, 169TWN, 169T22, 169T01, 169T00, 169T14, 169U86, 169U87, 169U8D, 169U8K, 169U8T, 169UML, 169UN6, 169UNL, 169UM8, 169UNH, 169UPD, 169UU0, 169URY, 169UTF, 169ULK, 169UT7, 169UMY, 169UTT, 169W85, 169VJX, 169V82, 169VJU, 169VJP, 169W4J, 169VK6, 169WDD, 169WVL, 169VHC, 169VHJ, 169VH8, 169VH9, 169VHM, 169VHV, 169Y4W, 169Y65, 169Y6M, 16A135, 169Y54, 16A0P5, 169Y68, 169Y49, 16A0LY, 169Y86, 16A0MU, 16A0L9, 16A0LM, 16A0KY, 169Y8P, 169Y8D, 16A30F, 16A245, 16A249, 16A24F, 16A37T, 16A30J, 16A37R, 16A24R, 16A24M, 16A326, 16A23M, 16A23H, 16A30L, 16A32J, 16A31M, 16A2JA, 16A2FJ, 16A31E, 16A3EY, 16A37N, 16A4C0, 16A4VJ, 16A79X, 16A6M7, 16A5ED, 16A68D, 16A6MT, 16A5EA, 16A55J, 16A4UM, 16A4U7, 16A55V, 16A4VX, 16A7AU, 16A55N, 16A552, 16A6L6, 16A4UV, 16A5E9, 16A4MN, 16A7A1, 16A78M, 16A7AC, 16A4RX, 16A55W, 16A7A8, 16A695, 16A78P, 16A5EN, 16A56F, 16A4MJ, 16A54X, 16A55D, 16A68W, 16A55K, 16A7A0, 16A7Y9, 16A9JL, 16A7YM, 16A88E, 16A80E, 16A80X, 16A9JC, 16A84X, 16A80N, 16A812, 16A9LP, 16A9JX, 16A8Y5, 16A885, 16A87T, 16A858, 16A7TT, 16A86W, 16AAL1, 16AALP, 16AAMP, 16AAM2, 16ACKC, 16ACHM, 16ACHE, 16ACFD, 16ACFE, 16ACHF, 16ACFF, 16ACJ6, 16ACFH, 16ACJ8, 16ACFL, 16ACHT, 16ACR2, 16ACJ0, 16ACH7, 16ACJL, 16AE8X, 16AEKK, 16AEL7, 16AE8A, 16AEK3, 16AEK2, 16AE8C, 16AEK6, 16AE8L, 16AE7R, 16AE8N, 16AHT7, 16AJ1U, 16AH1C, 16AH12, 16AJCE, 16AH0H, 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16D50Y, 16D6VW, 16D88F, 16D6VR, 16D6VY, 16D7U7, 16D6VJ, 16D88P, 16D7P4, 16D88Y, 16D88X, 16D892, 16D7PJ, 16D7NN, 16D7VP, 16D88W, 16D894, 16D7X9, 16D7PU, 16D6WJ, 16D6V1, 16D6V8, 16D8AV, 16D88C, 16D6WF, 16D7RJ, 16D7PD, 16D7PV, 16D6VP, 16D7NR, 16D7P7, 16D7RN, 16D88N, 16D8A8, 16DAC3, 16DACP, 16D8WJ, 16DAD9, 16D9KU, 16D8W8, 16D9L8, 16DACN, 16D9L1, 16D94K, 16D9JX, 16D9LF, 16D9JN, 16D8V2, 16D93X, 16D8WW, 16D9K2, 16D9LL, 16D9U8, 16DAD8, 16DACD, 16D8WD, 16D9K9, 16D94A, 16DAD2, 16D94F, 16D9K5, 16D9TH, 16DAC2, 16DAD3, 16DCFR, 16DCCU, 16DCFU, 16DC98, 16DCCP, 16DCH1, 16DC8X, 16DCH2, 16DCLA, 16DDM0, 16DDLN, 16DCEH, 16DF36, 16DFLP, 16DETX, 16DEWA, 16DEUE, 16DEPW, 16DFJ8, 16DFFA, 16DEUR, 16DEU0, 16DEWF, 16DETY, 16DETA, 16DETD, 16DETC, 16DEWJ, 16DKEA, 16DKDP, 16DL1R, 16DN6A, 16DN6U, 16DN5V, 16DNRM, 16DNRK, 16DNKP, 16DNN7, 16DNMJ, 16DNPT, 16DNKA, 16DNKR, 16DR4U, 16DR4Y, 16DT5C, 16DR3K, 16DTCD, 16DT59, 16DPPP, 16DR3W, 16DTC9, 16DVV8, 16DVFF, 16DVFE, 16DVJC, 16DVF4, 16DVJ4, 16DU5A, 16DVL1, 16DVVR, 16DVF9, 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16EMF5, 16EMF7, 16EMEH, 16EMM4, 16EMF9, 16EMF4, 16EMEX, 16EMEF, 16EMKA, 16EMKX, 16EMDL, 16EMJH, 16EMJR, 16EMHD, 16EMLK, 16EMF3, 16EMDV, 16ENDE, 16ENEP, 16ENEU, 16ENL5, 16EP2L, 16ERJR, 16ERH4, 16ERHD, 16ERFJ, 16EREW, 16ERFM, 16ETU0, 16EV8R, 16EV70, 16ETUF, 16EUX2, 16ETRM, 16EU0L, 16EU0D, 16EV6N, 16ETVH, 16EUYH, 16EUW9, 16EUYF, 16EUVV, 16ETTN, 16EUVH, 16EUW3, 16ETYJ, 16EU10, 16EUWU, 16EUXF, 16EUXD, 16ETWM, 16EV75, 16EXEL, 16EXFU, 16EXEM, 16EW64, 16EW69, 16EW6F, 16EW7R, 16EW6V, 16EY12, 16EW8U, 16EW87, 16EW9T, 16EXXW, 16EXEX, 16EW8X, 16EXEU, 16EXX7, 16EXXN, 16EXET, 16EXEY, 16EXFN, 16EW92, 16EXDD, 16F029, 16F1X4, 16F1X5, 16F01P, 16F0AJ, 16F02R, 16F04P, 16F1M8, 16F29M, 16F27J, 16F025, 16F1X2, 16F1XK, 16F25L, 16F1YA, 16F1X3, 16F1XM, 16F1YD, 16F3ED, 16F3L7, 16F3KX, 16F3E7, 16F3HA, 16F3FW, 16F3FX, 16F3F1, 16F4NR, 16F5A7, 16F5AT, 16F5C0, 16F5C4, 16F5AV, 16F5L4, 16F8DV, 16F898, 16F894, 16F897, 16F88C, 16F81V, 16F7YP, 16F7YE, 16F87M, 16F824, 16F7YY, 16F885, 16F9C9, 16F9C5, 16FAKC, 16F9C0, 16F97K, 16F9C8, 16F9C6, 16F9C3, 16F9C4, 16F9AW, 16F94J, 16F94Y, 16F93E, 16FA72, 16FA77, 16F951, 16FA76, 16FA80, 16FA87, 16FEDM, 16FD7L, 16FDJA, 16FDML, 16FD8K, 16FDMK, 16FDM0, 16FCA5, 16FD7A, 16FFCA, 16FHHT, 16FHHW, 16FHHY, 16FF8W, 16FF8Y, 16FHJ0, 16FF6F, 16FHHM, 16FHK6, 16FFDD, 16FF9K, 16FHJX, 16FJYD, 16FK01, 16FJY7, 16FJXP, 16FJYV, 16FJYY, 16FR4T, 16FPLA, 16FPK8, 16FPM5, 16FPJ7, 16FPKW, 16FPLK, 16FPKM, 16FPLX, 16FPJT, 16FPK7, 16FT82, 16FU60, 16FT73, 16FUY4, 16FT6R, 16FU82, 16FT74, 16FUY6, 16FT76, 16FT6W, 16FT8V, 16FTDC, 16FT8R, 16FU6D, 16FU8A, 16FT8F, 16FU91, 16FU8C, 16FU8U, 16FU6V, 16FU8L, 16FT80, 16FU75, 16FU65, 16FTD7, 16FU7C, 16FU69, 16FU5X, 16FT7H, 16FX5K, 16FW58, 16FX7D, 16FX7A, 16FX5R, 16FY2X, 16FX50, 16FVYE, 16FVYA, 16FX3X, 16FX56, 16FX4M, 16FVYM, 16FX3M, 16FX4T, 16FX32, 16FX7M, 16FX5U, 16FX4F, 16FX55, 16FX3H, 16H05C, 16H05D, 16H05E, 16H05F, 16H0AW, 16H0AL, 16H0C1, 16H0C5, 16H0C2, 16H0AU, 16H21C, 16H0A3, 16H0AY, 16H0C6, 16H05H, 16H210, 16H0CV, 16H0CW, 16H1HV, 16H03T, 16H1DY, 16H03X, 16H096, 16H09H, 16H041, 16H1CW, 16H1HW, 16H088, 16H0AH, 16H055, 16H1HR, 16H21F, 16H047, 16H09V, 16H0CA, 16H1CU, 16H1E3, 16H1HL, 16H1DD, 16H03P, 16H21H, 16H2XN, 16H37U, 16H30U, 16H2Y5, 16H2YA, 16H2YH, 16H4AC, 16H340, 16H302, 16H2Y4, 16H49A, 16H2Y0, 16H4A5, 16H49E, 16H33D, 16H36M, 16H2XW, 16H30E, 16H49P, 16H4AM, 16H4A1, 16H2XX, 16H360, 16H5F7, 16H5EV, 16H5FE, 16H5E7, 16H5FF, 16H5ER, 16H7A3, 16H7A4, 16H79C, 16H78K, 16H7CF, 16H79P, 16H791, 16H79U, 16H7A9, 16H7C8, 16H9F1, 16H9J5, 16H9TA, 16H9FX, 16H9KA, 16H9RU, 16H9TR, 16H9TX, 16HCKE, 16HCFC, 16HCP7, 16HCCW, 16HCDF, 16HCFJ, 16HE8N, 16HE83, 16HE8K, 16HDRC, 16HCK2, 16HCKH, 16HCKC, 16HDPR | 384,851 units |
| Z-2649-2024 | Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065771541; UDI-DI: 00380657715411; Lot numbers: 168NME, 168NND, 16AV17. | 5,039 units |
| Z-2650-2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065772245; UDI-DI: 00380657722457; Lot numbers: 15P7PW, 15TFMD, 15TFME, 15TFMF, 15W7U4, 15W7U5, 15W7U6, 15W7U7, 15W7U8, 15W993, 169KKN, 169KKP, 169KKR, 169KKT, 169KRX. | 13,824 units |
| Z-2651-2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065772265; UDI-DI: 00380657722655; Lot numbers: 15P7RH, 15P7RK, 15TFMJ, 15V034. | 1,152 units |
| Z-2652-2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065772445; UDI-DI: 00380657724451; Lot numbers: 15V018, 15V019, 15V01A, 15V01C, 15V01D, 15V036, 15W7UE, 15W7UF, 15W7UH, 15W7UJ, 15W996, 15W997, 161960, 161961, 161962, 161963, 167PR0, 167PT9, 168NM5, 168NM6, 168NM7, 168NN9, 168NNA, 168NNC, 168YFW, 169KL0, 169KL1, 169KL2, 169KL3, 169KTC, 169KTE, 169KTH. | 29,814 units |
| Z-2653-2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065772465; UDI-DI: 00380657724659; Lot numbers: 15P7RN, 15TFMK. | 1,932 units |
| Z-2654-2024 | Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065772745; UDI-DI: 00380657724659; Lot numbers: 1668AM, 1668CX, 167PPX, 167PPY, 167PT5, 168NM3, 168NM4, 168NMW, 168NMX, 169KT6, 169KKV, 169KT5, 16ALNW, 16AUL2, 16DDRC, 16DDY6, 16DDY7, 16DDYW, 16F206, 16DDYV, 16FXK8. | 18,726 units |
| Z-2655-2024 | Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065911901; UDI-DI: 00380659119019; Lot numbers: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, 16J9AE. | 14,216 units |
| Z-2656-2024 | Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065912001; UDI-DI: 00380659120015; Lot numbers: 15W9CJ, 161A10, 161A2M, 163701, 164WWX, 16D4VU. | 39,954 units |
| Z-2657-2024 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065921541; UDI-DI: 00380659215414; Lot numbers: 15W7XT, 15W7Y8, 15W7Y9, 15W9E6, 15W9E8, 15X5JJ, 15X56A, 15X56C, 15X5KV, 15X5KX, 1618UH, 1618UJ, 161A1K, 1618V4, 1618V5, 161A21, 161A22, 162WY5, 162WY6, 162WYL, 162WYN, 1636Y8, 1636Y9, 1636YV, 164RXL, 164RY8, 164RYA, 164WV3, 164WW9, 164WWC, 1668MR, 1668MT, 1668NH, 1668NJ, 1668NK, 166E89, 166E90, 166E91, 167PVK, 167R34, 167PW7, 167PW8, 167PW9, 167R3K, 167R3L, 168TE8, 168UEX, 168TEN, 168UFJ, 168UFL, 169L38, 169L3M, 169P3C, 169P3D, 16ALXE, 16ALXF, 16AM34, 16ALY0, 16AM36, 16AV03, 16AV1T, 16DFKA, 16DFXT, 16DFL0, 16DFY7, 16DFY8, 16DNJ4, 16DNJN, 16DNJP, 16DNP3, 16DNP4, 16EM6V, 16EM6W, 16JAVH, 16JAVJ, 16JAVK, 16JAVL, 16JAVM. | 469,173 units |
| Z-2658-2024 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065982465; UDI-DI: 00380659824654; Lot number: 169L42 | 6,020 units |
| Z-2659-2024 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065983065; UDI-DI: 00380659830655; Lot number: 164RY1. | 2,520 units |
| Z-2660-2024 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065983265; UDI-DI: 00380659832659; Lot numbers: 16JV6H, 16DFL3. | 7,598 units |
| Z-2661-2024 | Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065990002; UDI-DI: 00380659900020; Lot numbers: 169L2V, 16H1KP. | 9,384 units |
| Z-2662-2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992245; UDI-DI: 00380659924453; Lot numbers: 168UH0, 16H1L6. | 11,916 units |
| Z-2663-2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992445; UDI-DI: 00380659924453; Lot numbers: 169P2R, 16AV06, 16AV1Y, 16F1JU, 16K9HA, 167R42. | 35,199 units |
| Z-2664-2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992561; UDI-DI: 00380659925610; Lot number: 16ALWU. | 3,419 units |
| Z-2665-2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992647; UDI-DI: 00380659926471; Lot number: 15X5KP. | 5,487 units |
| Z-2666-2024 | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992745; UDI-DI: 00380659927454; Lot numbers: 15X55P, 161A1C, 162WXV, 162WXW, 162WXX, 1636Y1, 1668MJ, 1668MK, 167R2Y, 168UEV, 16DFK6, 16DFXL, 16DNHY, 16EV4J, 16EV4K, 16F1PT, 16FXNX, 16FXNY, 16H1K6, 16J7UC, 1668NN, 169P3F, 16AM3T, 16AV0F, 16DFY9, 16EV4N. | 145,248 units |
| Z-2667-2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992747; UDI-DI: 00380659927478; Lot numbers: 1636Y0, 164RX6, 166E81, 166E82, 16ALX5, 16DNMV, 1618V6, 16AM3U, 16AV0E. | 53,123 units |
| Z-2668-2024 | Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065992761; UDI-DI: 00380659927614; Lot numbers: 1636XM, 16EV4H, 1618VR, 167PWV, 16J7VA. | 30,268 units |
| Z-2669-2024 | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065993045; UDI-DI: 00380659930454; Lot numbers: 164RXE, 16F1PX. | 11,676 units |
| Z-2670-2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A; Model/Catalog Number: 8065993047; UDI-DI: 00380659930478; Lot numbers: 1668MH, 16AUYX, 16DNHX. | 15,222 units |
| Z-2671-2024 | Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A; Model/Catalog Number: 8065000095; UDI-DI: 380650000958; Lot numbers: 16D1KR, 16D1KU, 16D1KV, 16D1KW, 16D1KX, 16FX1P, 16FX1R, 16HYDY, 16HYE0, 16HYE1. | 7,713 units |
| Z-2672-2024 | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A; Model/Catalog Number: 8065000093; UDI-DI: 380650000934; Lot numbers: 16HY6X. | 1,061 units |
| Z-2673-2024 | Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A; Model/Catalog Number: 8065751617; UDI-DI: 380657516179; Lot numbers: 16D1KA, 16D1KC, 16HE5E. | 3,197 units |
| Z-2674-2024 | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A; Model/Catalog Number: 8065751618; UDI-DI: 380657516186; Lot number: 16D1KN. | 324 units |
| Z-2675-2024 | Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A; Model/Catalog Number: 8065751767; UDI-DI: 380657517671; Lot numbers: 16C9ND, 16C9NE, 16C9NF, 16HE5R, 16HYDK. | 3,791 units |
| Z-2676-2024 | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A; Model/Catalog Number: 8065752437; UDI-DI: 380657524372; Lot numbers: 16AUM5, 16C9RE, 16DDFN, 16HE6A, 16HYDP, 16HYDR, 16HYDT. | 7,108 units |
| Z-2677-2024 | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A; Model/Catalog Number: 8065752438; UDI-DI: 380657524389; Lot numbers: 16C9RF, 16DDFT, 16DDFU, 16HE6E, 16HE6F, 16HYDW. | 4,766 units |
| Z-2678-2024 | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A; Model/Catalog Number: 8065752450; UDI-DI: 380657524501; Lot number: 16C9P7. | 1,057 units |
| Z-2679-2024 | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A; Model/Catalog Number: 8065752451; UDI-DI: 380657524518; Lot numbers: 16AUN4, 16AUN3, 16C9PX, 16C9PY, 16C9R0. | 4,481 units |
| Z-2680-2024 | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A; Model/Catalog Number: 8065753106; UDI-DI: 380657531066; Lot numbers: 16A6HW, 16A6HX, 16A6HY, 16AUNE, 16C9R3, 16HYFF, 16HYFJ. | 6,972 units |
What to do — step by step
Check Product Details
Look for the model number 8065992561 on the ophthalmic knife to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2664-2024 (July 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2664-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.