Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraoc

FDA device recall Z-0445-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Bausch and Lomb, Incorporated

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.

Action taken

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

Status

Terminated

Product code

NAA

Quantity affected

62 units

Distribution

Nationwide Distribution

Date initiated

2011-11-14

Date posted

2012-01-11

Date terminated

2012-05-23

Location

Aliso Viejo, CA