AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual

FDA device recall Z-2278-2014 · posted 2014-08-26 · Terminated

Recall details

Recalling firm

AMO Puerto Rico Manufacturing, Inc.

Reason for recall

Units may be labeled with the incorrect diopter power.

Action taken

AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.

Root cause

Error in labeling

Status

Terminated

Product code

HQL

Quantity affected

77,055 IOLs in total

Distribution

Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.

Date initiated

2014-05-13

Date posted

2014-08-26

Date terminated

2017-05-18

Location

Anasco, PR