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U.S. Department of Health and Human Services

Class 2 Device Recall Crystalens Accommodating Posterior Chamber Intraocular Lens

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 Class 2 Recall
Crystalens Accommodating Posterior Chamber Intraocular Lens
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on May 23, 2012
Recall Number Z-0445-2012
Recall Event ID 60565
Premarket Approval
PMA Number
P030002
Product Classification Lens,Intraocular,Accommodative - Product Code NAA
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.
Code Information Serial No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027 01/14/2016
Recalling Firm/
Manufacturer
Bausch and Lomb, Incorporated
30 Enterprise Ste 450
Aliso Viejo, California 92656-7115
Consumer Instructions No consumer action necessary
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NAA and Applicant = BAUSCH & LOMB, INC.
PMAs with Product Code = NAA and Applicant = EYEONICS, INC.
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