The Recall Desk
HighFDA (Devices)·Z-0028-2022·Announced 2021-10-13

FDA Recalls TECNIS Eyhance Intraocular Lenses for Elevated Endotoxin

Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device recall involving elevated endotoxin in an implanted medical device. No illnesses have been reported, but endotoxin contamination in intraocular implants poses a risk of infection. This qualifies as a high-risk product where injury has not yet been reported.

Plain-English summary

TECNIS Eyhance IOLs (intraocular lenses) with the TECNIS Simplicity Delivery System are permanent implants inserted into the eye during cataract surgery.

Certain distributed lenses contained endotoxin levels higher than both Johnson & Johnson's internal specification limit and the FDA's recommended endotoxin limit. The nonconforming lenses were released into distribution in error.

The recall affects lenses with Model DIU225U050 (UDI Code: (01)05050474745831(17)240414(21)5248142104, Serial Number 5248142104) distributed nationwide in Illinois.

Patients who received this lens should contact their eye care provider regarding the recall.

The recalled product

Product
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, disposabl
Manufacturer
Johnson & Johnson Surgical Vision Inc
Category
Medical Device — Ophthalmic / Intraocular Implant
Hazard
  • endotoxin
  • infection-risk

Distribution

Distributed nationwide across the United States.

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