STAAR Surgical identifies possible problems with three-piece Collamer IOL

MONROVIA, Calif. — STAAR Surgical (NASDAQ:STAA) has voluntarily initiated a recall of all Model CQ-2005V three-piece Collamer IOLs. The recall resulted from a potential packaging failure that company officials said could breach the sterility of the lens. The recall includes about 2.1% of IOLs currently in consignment inventory.

The IOLs used are used in cataract procedures and were introduced in limited release last October The recall was prompted when quality monitoring of existing inventory at STAAR’s Monrovia plant showed a potential for the pouches in which the lenses are packaged 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, according to company spokesmen.

“There have been no reports 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,” according to David Bailey, STAAR president and chairman.

Separately, STAAR 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 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. About 57% of the customers involved elected to participate in the exchange program.

Mr. Bailey added it was “too soon” to estimate what, if any, costs will arise from the recall and exchange programs.