{"recall":{"id":"fda-device-99496","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Johnson & Johnson Surgical Vision, Inc. recalls HEALON EndoCoat PRO","firm":"Johnson & Johnson Surgical Vision, Inc.","date":"2026-07-31","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"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)","code":"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","quantity":"111,478","number":"Z-3064-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.","nationwide":true,"states":[],"units":"111,478","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99496","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3d5e26034a5ebc0f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99496","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99496","recalling_firm":"Johnson & Johnson Surgical Vision, Inc.","address_1":"31 Technology Dr Ste 200","address_2":"N/A","postal_code":"92618-2302","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"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, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.","recall_number":"Z-3064-2026","product_description":"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)","product_quantity":"111,478","reason_for_recall":"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.","recall_initiation_date":"20260731","center_classification_date":"20260831","report_date":"20260909","code_info":"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","more_code_info":""}]}}