Lower riskMedical device recall · FDA · Published August 6, 2021
Johnson & Johnson Surgical Vision Recalls TECNIS Eyhance IOLs Due to Endotoxin Levels
Johnson & Johnson Surgical Vision recalls TECNIS Eyhance IOLs with endotoxin levels exceeding safety limits. This nonconforming product was distributed in error during cataract surgery procedures.
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Take action
Contact the company
📍Recalling firmJohnson & Johnson Surgical Vision Inc1700 E Saint Andrew Pl · Santa Ana, CA 92705-4933
“Johnson & Johnson Surgical Vision Recalls TECNIS Eyhance IOLs Due to Endotoxin Levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62019-johnson-johnson-surgical-vision-recalls-tecnis-eyhance-iols-due-to. Based on FDA recall #Z-0028-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2022%22&limit=1).
The FDA announced on August 6, 2021, that Johnson & Johnson Surgical Vision Inc. is recalling TECNIS Eyhance IOLs due to nonconforming endotoxin levels exceeding internal and FDA limits. The agency classified the recall as Class II.
The product was distributed in error due to endotoxin levels higher than both the firm's internal specification and the FDA recommended limit. The recall is classified as Class II.
Context
GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since May 9, 2018. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (July 31, 2026), Irrigation Sleecks for risk of insufficient flow (March 14, 2024), and TECNIS Toric II IOLs with an angle issue (December 12, 2023). Other recent recalls of similar products include eye surgery kits with high endotoxin levels (March 19, 2026), medical procedure kits recalled for potential endotoxin levels (March 19, 2026), and American Contract Systems Medical Kits for endotoxin variability risk (May 19, 2026).
How to tell if you have this one
Check for the model number DIU225U050 on the packaging or the UDI code (01)05050474745831(17)240414(21)5248142104. The product was produced with serial number 5248142104.
Brand
Johnson & Johnson Surgical Vision
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number DIU225U050 and UDI code (01)05050474745831(17)240414(21)5248142104 on the packaging or implant.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide distribution in the state of IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0028-2022 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0028-2022 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.