Recall Z-0028-2022— Johnson & Johnson Surgical Vision Inc

Name: FDA recall Z-0028-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Class II · Terminated

Class II FDA medical device recall by Johnson & Johnson Surgical Vision Inc, initiated 2021-08-06, terminated 2023-03-06. FDA's recall record names no specific 510(k) clearance for this event. 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, disposable insertion system for delivering the IOL into the eye during cataract surgery.. Reason: 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..

Recalling firm: Johnson & Johnson Surgical Vision Inc
Classification: Class II
Status: Terminated
Initiated: 2021-08-06
Terminated: 2023-03-06
Firm location: Santa Ana, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.