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.
FDA Recall Z-0445-2012 · Posted 2012-01-11
Advertisement
Recalling FirmBausch and Lomb, Incorporated
Recall StatusTerminated
Product CodeNAA
Date Initiated2011-11-14
Date Terminated2012-05-23
Product Quantity62 units
Reason for Recall
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.
Firm 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..
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement