Recall Z-1309-2015 ยท HQL Intraocular Lens
Aaren Scientific, Incorporated
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the ey
| Date | Mar 20, 2015 (initiated Feb 13, 2015) |
| Status | Terminated |
| Reason | Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements. |
| Root cause | Labeling design |
| Action | A customer notification letter dated 2/13/15 was sent to all customers who received the Intraocular Lens model EC-3 PAL. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to confirm receipt of the recall letter and to contact Mark Scheib at (909) 906-5119 or via email at mark.scheib@zeiss.com with any questions or comments. |
| Quantity | 28 units |
| Distribution | Distributed in the states of OK, KS, FL, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.