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Contact Lens Solution Recall
Editor's note: In May 2007, Advanced Medical Optics voluntarily recalled its Complete MoisturePlus multipurpose solution after reports of Acanthamoeba keratitis, a potentially serious parasitic infection.
Nov. 22, 2006 -- About 183,000 packages of 12-ounce Complete MoisturePLUS multipurpose contact lens solution and Complete MoisturePLUS Active Packs are being recalled due to possible bacterial contamination.
The FDA and Advanced Medical Optics (AMO), which makes the recalled products, say contact lens wearers should stop using the recalled products immediately.
People should remove their contacts and talk to an eye care specialist immediately if they experience eye infection symptoms such as redness, pain, tearing, increased sensitivity to light, blurry vision, discharge, or swelling, say the FDA and Advanced Medical Optics.
The recall only applies to 18 lots of the products, listed below.
"The vast majority" of Advanced Medical Optics' contact lens solution products distributed in the U.S. and Europe "are not affected by this recall," the company says.
Nonsterile contact lens solutions "may have serious health consequences, including eye infection," Advanced Medical Optics says in a news release that is posted on the FDA web site.
The company says it hasn't received any reports of health problems associated with the recalled product lots in the U.S.
Production Problem
The company blames production problems at a manufacturing plant in China for the problem.
Three lots of products made at that plant and sold in Japan were found to contain bacteria, the company says.
In light of that discovery, 18 lots of the products made at the Chinese plant and distributed in the U.S. are being recalled.
It doesn't affect 4-ounce or 16-ounce bottles, or samples and packs provided to eye-care professionals.
Recalled Products
Here is a chart from Advanced Medical Optics showing the recalled products.
Lot numbers can be found on the top of the product box and the side of the bottle.
|
Package Lot No.
|
Product Description
|
Bottled Lot Number(s) in Kit
|
|---|---|---|
|
ZB03087
|
COMPLETE MoisturePLUS Active Pack
|
ZB03085, ZB02845
|
|
ZB03724
|
COMPLETE MoisturePLUS Active Pack
|
ZB03713, ZB03506
|
|
ZB03734
|
COMPLETE MoisturePLUS Active Pack
|
ZB03713, ZB03506
|
|
ZB03735
|
COMPLETE MoisturePLUS Active Pack
|
ZB03713, ZB03510
|
|
ZB03736
|
COMPLETE MoisturePLUS Active Pack
|
ZB03713, ZB03510
|
|
ZB03739
|
COMPLETE MoisturePLUS Active Pack
|
ZB03737, ZB03510
|
|
ZB02710
|
COMPLETE MoisturePLUS 12oz (360 mL)
|
ZB02709
|
|
ZB02714
|
COMPLETE MoisturePLUS 12oz (360 mL)
|
ZB02713
|
|
ZB02718
|
COMPLETE MoisturePLUS 12oz (360 mL)
|
ZB02717
|
|
ZB02722
|
COMPLETE MoisturePLUS 12oz (360 mL)
|
ZB02721
|
|
ZB02746
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02745
|
|
ZB02750
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02749
|
|
ZB02771
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02770
|
|
ZB02792
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02791
|
|
ZB02796
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02795
|
|
ZB02800
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02799
|
|
ZB02804
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB02803
|
|
ZB03535
|
COMPLETE MoisturePLUS 2 X 12 oz
|
ZB03534
|
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