Malosa Core SMILE Pack 1 Medical Refractive Kit Recall: Packaging Holes Risk Contamination
Beaver Visitec recalls Malosa Core SMILE Pack 1 kits with potential packaging holes that could compromise sterility during surgery. Affected units include specific lot numbers for cataract, corneal, and refractive surgery procedures.
Lower-risk recall
Kit packaging may have small holes compromising product sterility
Contact the company
What happened, in plain English
Beaver Visitec is recalling Malosa Core SMILE Pack 1 medical kits used in eye surgery due to possible small holes in the packaging that might allow contamination. This could lead to infections if the kit is used without proper sterility. Read more at govinfonow.com/recall/61525-malosa-core-smile-pack-1-medical-refractive-kit-recall-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/61525-malosa-core-smile-pack-1-medical-refractive-kit-recall-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0409-2022
Cite this page
“Malosa Core SMILE Pack 1 Medical Refractive Kit Recall: Packaging Holes Risk Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61525-malosa-core-smile-pack-1-medical-refractive-kit-recall-packaging. Based on FDA recall #Z-0409-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0409-2022%22&limit=1).
Why it’s dangerous
The kit packaging may have small holes that could compromise the product's sterility. If the packaging is not sterile, the surgical kit might become contaminated during use, potentially leading to infections in patients.
Who’s affected
Surgical teams and medical facilities that purchased the Malosa Core SMILE Pack 1 kits with specific lot numbers listed in the recall. Patients undergoing cataract, corneal, or refractive surgery are at risk if the kit is used without proper sterility.
How to tell if you have this one
Check the product label for lot numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639. The kits are intended for cataract, corneal, or refractive surgery procedures.
- Brand
Beaver Visitec- Category
Medical device
All 6 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
CA, CO, LA, MA, MD, ND, PA, TN, UT
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0405-2022 | Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2; Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419 | 920 units |
| Z-0406-2022 | Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3; Lot Numbers: 3347921, 3358240 | 380 units |
| Z-0407-2022 | Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2; Lot Numbers: 3272267, 3274728, 3323887 | 120 units |
| Z-0408-2022 | Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1; Lot Numbers: 3289074 | 30 units |
| Z-0409-2022 | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884; Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639 | 680 units |
| Z-0410-2022 | Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967; Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371 | 1170 units |
What to do — step by step
Check Packaging for Holes
Inspect the kit packaging for small holes that could compromise sterility.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “CA, CO, LA, MA, MD, ND, PA, TN, UT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Louisiana, Maryland, Massachusetts, North Dakota, Pennsylvania, Tennessee, Utah.
Recall timeline
FDA published this recall 42 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-0409-2022 (November 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0409-2022 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.