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Terminated

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).

FDA Recall Z-2706-2011 · Posted 2011-06-29

Recalling FirmStaar Surgical Co.
Recall StatusTerminated
Product CodeHQL
Date Initiated2011-05-20
Date Terminated2014-03-04
Product Quantity16,750 devices distributed to the field

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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