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U.S. Department of Health and Human Services

Class 2 Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single

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  Class 2 Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single see related information
Date Initiated by Firm May 20, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on March 04, 2014
Recall Number Z-2706-2011
Recall Event ID 59028
PMA Number P990013 
Product Classification Intraocular lens - Product Code HQL
Product Brand Name
STAAR Surgical Collamer¿ Ultraviolet-Absorbing Posterior Chamber Single
Piece Foldable Intraocular Lens
Common Names
Collamer single piece IOL
Collamer plate haptic IOL

The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
Code Information CC4204BF and CC4204A
Recalling Firm/
Manufacturer		 Staar Surgical Co.
1911 Walker Ave
Monrovia CA 91016-4846
For Additional Information Contact Jolie Krance
626-303-7902
Manufacturer Reason
for Recall		 The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.
FDA Determined
Cause 2		 Other
Action Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.
Quantity in Commerce 16,750 devices distributed to the field
Distribution Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = HQL and Original Applicant = STARR SURGICAL CO.
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