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.
Johnson & Johnson Surgical Vision has recalled TECNIS Eyhance IOLs that were distributed in error with endotoxin levels higher than both their internal and FDA safety limits. This could pose a risk during cataract surgery if the implants are used.
The recalled IOLs had endotoxin levels higher than both the manufacturer's internal standards and FDA recommendations. Endotoxins are bacterial components that can cause inflammation or infection if introduced into the eye during surgery.
Patients who received the recalled TECNIS Eyhance IOLs during cataract surgery are affected. Surgeons and ophthalmologists who used these implants are most at risk.
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.
Verify the model number DIU225U050 and UDI code (01)05050474745831(17)240414(21)5248142104 on the packaging or implant.
The TECNIS Eyhance IOLs were distributed in error with endotoxin levels higher than both the manufacturer's internal and FDA safety limits.
Patients who received the recalled IOLs during cataract surgery may be at risk for inflammation or infection if the implants were used.
Check for the model number DIU225U050 and UDI code (01)05050474745831(17)240414(21)5248142104 on the packaging or implant.
We’ve drafted a message you can send Johnson & Johnson Surgical Vision to request your refund or repair — edit it as you like.
Subject: Recall Z-0028-2022 — Johnson & Johnson Surgical Vision Johnson & Johnson Surgical Vision Hello, I own a Johnson & Johnson Surgical Vision that is covered by recall Z-0028-2022 from Johnson & Johnson Surgical Vision. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
