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Use caution Medical device recall · FDA · Published July 31, 2026

Johnson & Johnson Surgical Vision Recalls HEALON Products for Corneal Injury Risk

Johnson & Johnson Surgical Vision recalls HEALON EndoCoat PRO and HEALON DUET PRO II products due to risk of corneal abrasion or eye damage if cannula is forced during cataract surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3064-2026Medical deviceJohnson & Johnson Surgical Vision ›
✎ GovInfoNow plain-language explainer

Johnson & Johnson Surgical Vision is recalling specific HEALON EndoCoat PRO and HEALON DUET PRO II products used in cataract surgery. Forcing the surgical cannula during insertion could cause corneal abrasion, iris trauma, or damage to the eye's inner layer, which requires immediate attention. Read more at govinfonow.com/recall/843291-johnson-johnson-surgical-vision-recalls-healon-products-for-corneal-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/843291-johnson-johnson-surgical-vision-recalls-healon-products-for-corneal-injury · Updated September 16, 2026 · FDA enforcement record: FDA #Z-3064-2026

Cite this page

“Johnson & Johnson Surgical Vision Recalls HEALON Products for Corneal Injury Risk.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/843291-johnson-johnson-surgical-vision-recalls-healon-products-for-corneal-injury. Based on FDA recall #Z-3064-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3064-2026%22&limit=1).

The FDA announced on July 31, 2026, that Johnson & Johnson Surgical Vision is recalling HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products because incorrect surgical instructions may lead to eye trauma. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Johnson & Johnson Surgical Vision
  • Product: HEALON EndoCoat PRO, REF: 10300012 (US/CAN)
  • Product: HEALON DUET PRO II, REF: 10300016 (US/CAN)
  • Product: HEALON EndoCoat PRO, REF: 10301012 (EU)
  • Product: HEALON DUET PRO II, REF: 10301016 (EU)
  • Lot codes: UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205
  • Lot codes: UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175
  • Lot codes: UB33014, UB33041, UB33057, UB33060, UB33100, UB33190
  • Lot codes: UB33084, UB33194

The hazard

The recall involves surgical instructions for viscoelastic products used during ophthalmic viscosurgical cataract procedures. The instructions state that forcing the cannula if resistance is encountered may cause corneal abrasion, iris trauma, or descemet's membrane detachment.

Context

GovInfoNow's records show Johnson & Johnson Surgical Vision has 14 other recalls on record since May 9, 2018. Other recent recalls of similar products include Johnson & Johnson VISION Recalls Irrigation Sleeves (March 14, 2024), Johnson & Johnson Surgical Vision Recalls TECNIS Toric II IOLs with Angle Issue (December 12, 2023), and Johnson & Johnson Surgical Vision recalls TECNIS Symfony IOLs with unintended toric marks (July 6, 2023). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026), Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026), and Covidien Surgipro SP-623 Sutures Recall (June 24, 2026).

How to tell if you have this one

Check for the product name and reference codes listed: HEALON EndoCoat PRO (REF: 10300012 or 10301012) or HEALON DUET PRO II (REF: 10300016 or 10301016). The specific lot numbers and UDI-DI codes are also listed in the recall notice.

  • Brand
    Johnson & Johnson Surgical Vision
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Recalled Products

    If you have the recalled HEALON EndoCoat PRO or HEALON DUET PRO II products, stop using them immediately to prevent potential eye damage.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Jul 31, 202612. FDA classified it Class II: Aug 31, 202623. Published in FDA’s Enforcement Report: Sep 9, 202634. Added to GovInfoNow: Sep 15, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

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-3064-2026 (July 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3064-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 16, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA