Recall Z-1079-2012 ยท HQL Intraocular Lens
Aaren Scientific, Incorporated
UV-Absorbing Posterior Chamber IOL Model: SP-65A2, Serial Number: 1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, 1168581106, 1168591106, 1168601106, 1168611106. 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 catar
| Date | Feb 22, 2012 (initiated Aug 2, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label. |
| Root cause | Incorrect or no expiration date |
| Action | Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify yo |
| Quantity | 15 units |
| Distribution | Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.