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STAAR recalls Collamer IOL due to potential packaging problem
No clinical problems were reported with the lens. In a separate action, the company offered exchanges for some of its silicone lenses.
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MONROVIA, Calif. — STAAR Surgical voluntarily recalled all of its model CQ-2005V lenses in June. The three-piece Collamer IOL was introduced in a limited release in October.
The recall was initiated because of a potential packaging failure that could breach the sterility of the lens.
Company officials emphasized that there were no reports of clinical effects from the packaging flaw, and in fact there were no reports of any packaging failure. The voluntary recall was undertaken to ensure patient safety.
The recall includes approximately 2.1% of STAAR IOLs currently in consignment inventory.
STAAR officials said 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 the company, 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 are not affected by this action.
No clinical adverse events
David Bailey, STAAR’s president and chairman, commented in a press release, “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 ensure 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 3-Piece Collamer Lens.”
Nancy Morris, vice-president of marketing for STAAR, reiterated that there have been no reports of any clinical problems with the lens. She said the company was required by Food and Drug Administration regulations to recall the lenses, and doctors and hospitals were required to send back the affected lenses.
Ms. Morris explained that as some CQ-2005V lenses were being prepared for shipping, STAAR’s quality assurance staff found that some of the lens pouches had poor seals. Further investigation by company personnel revealed that the problem was found throughout the lens supply.
STAAR officials said they are working on a way of replacing the lenses; however, because the recall affects their entire current supply, they are uncertain when replacement lenses will be made available.
Because the Collamer IOLs are manufactured separately and with a different process, no other STAAR lenses are affected by the suspect packaging or the recall.
Silicone lens tears
Separately, STAAR Surgical announced that a letter was sent to customers in early April offering them silicone IOLs 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. According to STAAR, approximately 57% of the doctors and hospitals involved elected to participate in the exchange program.
Ms. Morris explained that there is no danger to IOLs already implanted in patient’s eyes. The silicone lenses were found to tear only when implanted through an injector. Once implanted there is no need for explantation.
Mr. 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.”
For Your Information:
- For more information on the recall of the Collamer IOL and the exchange program for certain silicone IOLs, contact STAAR Surgical, 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 303-2962; Web site: www.staar.com.