Z-0445-2012

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

Name: Z-0445-2012 Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior...
Creator: Bausch and Lomb, Incorporated
Published: 2011-11-14
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2011-11-14 / Terminated / root cause: manufacturing process

FDA source

Bausch and Lomb, Incorporated began a recall of Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The... on 2011-11-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0445-2012
Status: Terminated
Initiated: 2011-11-14
Posted: 2012-01-11
Terminated: 2012-05-23
Recalling firm: Bausch & Lomb Incorporated
Product: 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.
Product code: NAA Lens, Intraocular, Accommodative
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 62 units
Distribution: Nationwide Distribution
Product codes and lots: Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016

Product code NAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)