Recall Z-0694-2020 ยท HQL Intraocular Lens
Tekia, Inc.
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
| Date | Nov 9, 2018 |
| Status | Terminated |
| Reason | A limited number of lenses may be mislabeled with the incorrect diopter power. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 11/9/2018 notifying the consignee to take the following actions: 1) to stop using the device and remove the product from inventory, 2) inform TEKIA by email (sahil@tekia.com, pascale@tekia.com) within 3 working days of all the retrieved and already implanted Single Piece Hydrophilic Acrylic IOLs listed in the letter, including serial numbers, and 3) destroy the product once every affected IOL is removed out from your inventory and forward evidence of destruction with corresponding serial numbers by email (sahil@tekia.com, pascale@tekia.com). If you have |
| Quantity | 81 IOLs were distributed but only 36 within expiry were recalled |
| Distribution | There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.