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 fo
Check against the official notice below — it lists the full affected range.
Johnson & Johnson Surgical Vision Inc. is recalling one TECNIS Eyhance intraocular lens (IOL) implant with Model DIU225U050 and Serial Number 5248142104. The lens was distributed in error because it had endotoxin levels that exceeded both the company's internal specification limit and the FDA's recommended endotoxin specification limit. The nonconforming product was released based on additional testing results performed during an investigation into release testing problems. The affected lens was distributed nationwide in Illinois.
The recall notice does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: U.S. Nationwide distribution in the state of IL. Quantity: 1 lens Lot/code info: Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.