Recall Z-0735-2024— Johnson & Johnson Surgical Vision, Inc.
Class II · Ongoing
Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2023-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: TECNIS Toric II OptiBlue IOL Models ZCW. Reason: Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks..
- Recalling firm
- Johnson & Johnson Surgical Vision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-12
- Firm location
- Irvine, CA, United States
Product description
TECNIS Toric II OptiBlue IOL Models ZCW
Reason for recall
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.