Recall Z-3064-2026
- Recall number
- Z-3064-2026
- Event number
- 99496
- Firm
- Johnson & Johnson Surgical Vision, Inc.
- Firm FEI
- 3012236936
- Product code
- LZP
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-08-31
- Root cause
- Device Design
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 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.