Recall Z-0445-2012 ยท NAA Lens, Intraocular, Accommodative
Bausch and Lomb, Incorporated
Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
| Date | Jan 11, 2012 (initiated Nov 14, 2011) |
| Status | Terminated |
| Reason | Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination. |
| Root cause | Nonconforming Material/Component |
| Action | Bausch + Lomb sent an "URGENT- MEDICAL DEVICE RECALL" letter dated November 14, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to remove the affected products from inventory and return the lenses to the firm. Additionally, a Recall Acknowledgement Form was attached to the letter for customers to complete and return with the affected products. Contact Bausch + Lomb at 949-521-7895 for questions regarding this recall.. |
| Quantity | 62 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.