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STAAR Surgical Identifies Potential Packaging Problem with Three-Piece Collamer(TM) IOL

  • 2001-06-12
  • Press release
MONROVIA, Calif., Jun 12, 2001 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA) announced today that it has voluntarily initiated a recall of all Model CQ-2005V, a three-piece Collamer(TM) intraocular lens used in cataract procedures introduced in a limited release in October. The recall resulted from a potential packaging failure, which could breach the sterility of the lens. It includes approximately 2.1 percent of IOLs currently in consignment inventory.

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. Approximately 57 percent of the customers involved elected to participate in the exchange program.

Bailey added, "It is too soon to know what, if any costs will be involved in the implementation of the recall or the exchange. We are conducting a full review of our quality assurance program in keeping with the pledge I made to shareholders at the annual meeting May 25 to review and improve all operations of the Company."

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) that is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) collagen glaucoma drainage device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) and the 3-piece Collamer(TM) IOL available in Europe and all except the ICL(TM) in the United States.

Certain statements in this press release constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements involve risks and uncertainties that may cause the Company's actual results to be materially different.

For additional information, about STAAR Surgical, visit the Company's web site at or . You may wish to 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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SOURCE STAAR Surgical Company

CONTACT:          David Bailey, President, or John Santos, Chief Financial
                  Officer, 626-303-7902, both of STAAR Surgical; or Bill Roberts, President, or
                  Ellen Geron, 937-434-2700, both of CTC, Inc.