Recall found. Johnson & Johnson Surgical Vision is named in FDA Class II recall Z-3064-2026 covering HEALON EndoCoat PRO.
Hazard: 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. Identifying details: REF/UDI-DI/Lot: 10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205; 10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175; 10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190; 10301016/5050474755123/UB33084, UB33194. Status: Ongoing.
FDA Class II · Medical device · September 9, 2026
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, with…
Official ID Z-3064-2026 ·
Official record ↗
Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.