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U.S. Department of Health and Human Services

Class 2 Device Recall AKREOS AO Micro Incision Lens

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 Class 2 Device Recall AKREOS AO Micro Incision Lenssee related information
Date Initiated by FirmOctober 16, 2013
Date PostedFebruary 20, 2014
Recall Status1 Terminated 3 on September 17, 2014
Recall NumberZ-1062-2014
Recall Event ID 67283
PMA NumberP060022 
Product Classification intraocular lens - Product Code HQL
ProductBausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL 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.
Code Information Model Numbers(s): AO60 and MI60L
Recalling Firm/
Manufacturer		 Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information ContactGlenn Mattei
727-724-6600
Manufacturer Reason
for Recall		Lens was manufactured with incorrect raw material.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, Bausch + Lomb, telephoned and sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 17, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Determine the disposition of the lenses; 2) Complete and provide the enclosed acknowledgement form to the sales respresentatives collecting the lenses, and 3) Return all unused products. If you have any questions, please contact Bausch + Lomb at (800) 338-2020.
Quantity in Commerce336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
DistributionWorldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = HQL
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