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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
- Hazard
- Affected units
- 1
Distribution
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