Recall Z-2289-2023— Johnson & Johnson Surgical Vision, Inc.

Name: FDA recall Z-2289-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-06

Class II · Ongoing

Class II FDA medical device recall by Johnson & Johnson Surgical Vision, Inc., initiated 2023-07-06. FDA's recall record names no specific 510(k) clearance for this event. Product: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only. Reason: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks..

Recalling firm: Johnson & Johnson Surgical Vision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-06
Firm location: Irvine, CA, United States

Product description

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Reason for recall

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

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