Ft Worth TX - Dec 14, 2006 //Press Release// - Alcon Laboratories,
Inc., a subsidiary of Alcon, Inc. (NYSE: ACL), announced today a
voluntary recall of Systane® Free LIQUID GEL lubricant eye drops.
This product is distributed only in the United States, including
Puerto Rico. No other formulations of Systane® lubricant eye drops
are included in this recall. This voluntary recall is in response
to 11 consumer reports citing the presence of foreign material.
Alcon has distributed over 5 million bottles of Systane® Free LIQUID
GEL since its introduction in January 2006.
After testing particles from the opened, partially used bottles
that were returned to Alcon, the company identified the foreign
material as mold. However, because of the characteristics of these
molds, the development of an infection is considered unlikely. In
fact, Alcon has received no reports of fungal infections associated
with the 11 reports. The company is taking this action to voluntarily
recall Systane® Free LIQUID GEL because eye drops that become contaminated
after opening the bottle may cause eye infections. Alcon has notified
the U.S. Food and Drug Administration of this voluntary action.
Alcon has tested returned product and retained samples from the
lots with reports of mold and has conducted a comprehensive review
of its manufacturing records. Based on this testing and analysis,
Alcon has determined that the cause of the product problem is the
specific formulation of Systane® Free LIQUID GEL, and is not the
result of any manufacturing processes. Therefore, the recall applies
only to Systane® Free LIQUID GEL. The original formulation of Systane®
lubricant eye drops and Systane® unit dose are not part of this
recall and can continue to be used safely.
Retailers, distributors, customers and consumers can identify
if their bottles are subject to the recall by locating the words
“Free” and “LIQUID GEL” on the product box or bottle. If these words
are not on the bottle or box, the product is safe for use and is
not subject to this recall. The picture provided shows where these
words are found on the bottle and box.
Consumers who are in possession of Systane® Free LIQUID GEL should
immediately discontinue use and call 1-866-608-3936 or visit www.systane.com
for instructions. The company is currently contacting retailers,
distributors and eye doctors to communicate return and replacement
instructions. These customers may also call 1-866-608-3936 for more
information. Reply cards and pre-paid mailing slips are being provided
for product return.
Alcon will replace any purchased bottles of Systane® Free LIQUID
GEL with a 15mL bottle of its original formulation of Systane® lubricant
eye drops. The original formulation of Systane® is based on the
Polyquad® preservative system that has been used for more than 20
years to prevent contamination of eye care products. Furthermore,
the original formulation of Systane® has been used safely by consumers
since 2003.
“Alcon is absolutely committed to providing the highest level
of quality eye care products,” said Kevin Buehler, Alcon’s senior
vice president, United States and chief marketing officer. “We took
this voluntary action even though it is unlikely that eye infections
would occur as a result of this issue.”
To reduce the potential for contamination of eye drops, consumers
should not touch the tip of the bottle to their eye, should not
allow anything else to touch the tip of the bottle and should always
put the cap on the bottle immediately after use. Consumers who have
concerns about the health of their eyes or who experience unusual
eye symptoms, such as severe pain, loss of vision, or significantly
increased sensitivity to light, should consult with their eye doctor
immediately.
