Johnson & Johnson Surgical Vision Inc: Medical Device Recall in 2021 - (Recall #: Z-0028-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 6, 2021

Date Posted: October 13, 2021

Recall Number: Z-0028-2022

Event ID: 88564

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.

Status: Terminated

Product Quantity: 1 lens

Code Information:

Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104

Distribution Pattern:

U.S. Nationwide distribution in the state of IL.

Voluntary or Mandated:

Voluntary: Firm initiated