Recall Z-3064-2026— Johnson & Johnson Surgical Vision, Inc.
Class II · Ongoing
Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2026-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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). 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..
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-31
- Firm location
- Irvine, CA, United States
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)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.