PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 13, 2021 Initiated: August 6, 2021 #Z-0028-2022

Product Description

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.

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.

Details

Units Affected
1 lens
Distribution
U.S. Nationwide distribution in the state of IL.
Location
Santa Ana, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Johnson & Johnson Surgical Vision Inc. Units affected: 1 lens.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0028-2022.

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