Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common

FDA device recall Z-2706-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Staar Surgical Co.

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.

Action taken

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

Status

Terminated

Product code

HQL

Quantity affected

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

Date initiated

2011-05-20

Date posted

2011-06-29

Date terminated

2014-03-04

Location

Monrovia, CA