TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

FDA device recall Z-0237-2016 · posted 2015-11-06 · Terminated

Recall details

Recalling firm

Tekia, Inc.

Reason for recall

Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

Action taken

Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300. Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.

Root cause

Error in labeling

Status

Terminated

Product code

HQL

Quantity affected

50 units

Distribution

Internationally to Vietnam.

Date initiated

2015-09-29

Date posted

2015-11-06

Date terminated

2015-12-03

Location

Irvine, CA