June 13, 2001STAAR Surgical Recalls
Intraocular Lens Product
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 STAARs
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, STAARs 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.