Recall Z-0237-2016 ยท HQL Intraocular Lens
Tekia, Inc.
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
| Date | Nov 6, 2015 (initiated Sep 29, 2015) |
| Status | Terminated |
| Reason | Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 50 units |
| Distribution | Internationally to Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.