{"url_path":"/fda/device/recalls/Z-3064-2026","section_key":"summary","section_title":"DEVICE Recall: Johnson & Johnson Surgical Vision, Inc. — HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016 (US/CAN)    HEALON EndoCoat PRO, REF: 10301012 (EU);  HEALON DUET PRO II, REF: 10301016 (EU)","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-31","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3064-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Johnson & Johnson Surgical Vision, Inc."},"word_count":211,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3064-2026\n\n**Recalling firm:** Johnson & Johnson Surgical Vision, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-31\n**Report date:** 2026-09-09\n\n## Product\nHEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016 (US/CAN)    HEALON EndoCoat PRO, REF: 10301012 (EU);  HEALON DUET PRO II, REF: 10301016 (EU)\n\n## Reason\nSurgical 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.\n\n## Affected lots\nREF/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\n\n## Distribution\nWorldwide - 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, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE."}