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U.S. Department of Health and Human Services

Class 2 Device Recall SoFlex SE Foldable Intraocular Lens

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 Class 2 Recall
SoFlex SE Foldable Intraocular Lens
see related information
Date Posted January 11, 2010
Recall Status1 Terminated on July 22, 2010
Recall Number Z-0591-2010
Recall Event ID 53949
Premarket Approval
PMA Number
P910061
Product Classification Intraocular Lens - Product Code HQL
Product Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
Code Information Model Number: LI61SE, Lot Number: 4916928.
Recalling Firm/
Manufacturer
Bausch & Lomb Inc
1400 North Goodman Street
Rochester, New York 14609-3547
For Additional Information Contact David Thomas
585-338-6000
Manufacturer Reason
for Recall
Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Bausch & Lomb, Inc. notified consignees via phone beginning November 19, 2009 and by follow-up letter dated November 23, 2009. Titled "Urgent - Medical Device Recall", the letter instructed users to discontinue implantation of the affected product and return any unused lenses along with the enclosed acknowledgement form to the firm. For further information, contact Bausch & Lomb at 1-585-338-6612.
Quantity in Commerce 85 lenses
Distribution Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.
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 = HQL and Applicant = BAUSCH & LOMB
PMAs with Product Code = HQL and Applicant = BAUSCH & LOMB SURGICAL, INC.
PMAs with Product Code = HQL and Applicant = BAUSCH & LOMB, INC.
PMAs with Product Code = HQL and Applicant = CHIRON VISION CORP.
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