Reported Oct 13, 2021 · Terminated
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS…
Johnson & Johnson Surgical Vision Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision Inc · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
- TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
- Lot codes and dates
- ModelDIU225U050
- UDI Code(01)05050474745831(17)240414(21)5248142104
- Production Order Number900001985625
- Serial Number5248142104
- Amount recalled
- 1 lens
Where it was sold
- Nationwide
- IL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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