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SafetyAlerts
June 13, 2001

STAAR Surgical Recalls Intraocular Lens Product

Monrovia, CA (SafetyAlerts) - STAAR Surgical Company is recalling all Model CQ-2005V, a three-piece Collamer(TM) intraocular lens used in cataract procedures. The recall resulted from a potential packaging failure, which could breach the sterility of the lens.

The recall was prompted when quality monitoring of existing inventory at STAAR’s Monrovia plant showed a potential for the pouches the lenses are packaged in to open while in their unit boxes after shipment from STAAR, possibly causing a breach in their sterility. The lenses are packaged in 5-ml glass vials and then in pouches. All other STAAR lenses are packaged differently and, thus, not affected by this action.

David Bailey, STAAR’s president and chairman commented, "There has been no report by customers of open pouches, nor has there been any report to date of a patient complication that could have been caused by this situation. However, we believe every precaution should be taken to insure the integrity of our product and, ultimately, the safety of the end user. For this reason, we run quality assurance checks on every aspect of our products and processes. This packaging problem has not dampened our enthusiasm for the Collamer 3-Piece Collamer Lens which we believe will be a leading contender in the future evolution of the IOL market."

Separately, STAAR Surgical announced that a letter was sent to customers in early April offering them an exchange for silicone lenses made from four specific lots of silicone all manufactured from a single lot of raw material. The letter was sent out after internal tests revealed that lenses made from these batches of silicone might be more prone to tearing although customer complaint data did not support this hypothesis.

For more information contact David Bailey, President, STAAR Surgical, or John Santos, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Ellen Geron, CTC Inc., please call (937) 434-2700.

 
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During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.