Reported Sep 9, 2026 · Ongoing · Updated Sep 14, 2026
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF:…
Johnson & Johnson Surgical Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- HEALON EndoCoat PRO
- REF10300012 (US/CAN) HEALON DUET PRO II
- REF10300016 (US/CAN) HEALON EndoCoat PRO
- REF10301012 (EU); HEALON DUET PRO II
- REF10301016 (EU)
- Lot codes and dates
4 of 4 products · 25 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lot 103000125050474755093UA32232UA32250UA32268UA32290UA32292UA32303UA32371UP31203UP31205
103000165050474755116UA32447UA32448UA32449UB33008UB33026UB33082UB33083UB33175
103010125050474755109UB33014UB33041UB33057UB33060UB33100UB33190
103010165050474755123UB33084UB33194
- Amount recalled
- 111,478
Where it was sold
Why it was recalled
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
This product could cause temporary or reversible health problems — stop using it.
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