Lower riskMedical device recall · FDA · Published December 12, 2023
Johnson & Johnson Surgical Vision Recalls TECNIS Toric II IOLs with Angle Issue
Johnson & Johnson Surgical Vision recalls specific TECNIS Toric II OptiBlue IOL models due to an angle out of specification in the intraocular lens, which may affect alignment during cataract surgery.
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.
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Contact the company
📍Recalling firmJohnson & Johnson Surgical Vision, Inc.31 Technology Dr Ste 200 · Irvine, CA 92618-2302
“Johnson & Johnson Surgical Vision Recalls TECNIS Toric II IOLs with Angle Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56571-johnson-johnson-surgical-vision-recalls-tecnis-toric-ii-iols-with. Based on FDA recall #Z-0735-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2024%22&limit=1).
Johnson & Johnson Surgical Vision, Inc. recalled TECNIS Toric II OptiBlue IOL Models ZCW due to an angle out of specification in the intraocular lens, according to the FDA on 2023-12-12.
The hazard is due to the intraocular lens containing an angle out of specification. The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Context
GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since 2018-05-09. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (2026-07-31), TECNIS Toric II OptiBlue IOL Models ZCW (2023-12-12), and TECNIS Eyhance IOL with unintended toric marks (2023-07-06). Other recent recalls of similar products include Staar ICL Software Version 8.00: Incorrect Implant Orientation Diagram Risk (2026-04-20), Kico ARVIS Surgical Navigation System Gen 2: Image May Appear Tilted (2026-07-13), and TECNIS Eyhance IOL with Simplicity Delivery System Recall: Haptic May Stick to Optic (2026-02-19).
How to tell if you have this one
Check if your intraocular lens has the model number ZCW and the listed serial numbers (e.g., 3473902107, 3474002107). These lenses were distributed internationally but not in the U.S.
Brand
Johnson & Johnson Surgical Vision
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Your Surgeon
Reach out to your eye surgeon to confirm if you received a recalled TECNIS Toric II OptiBlue IOL model ZCW with the listed serial numbers.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0735-2024 (December 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0735-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.