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Archive for May, 2006

European Link to Eye Fungus Outbreak Puts Pressure on Investigators and Bausch & Lomb to Find Answers

Friday, May 5th, 2006

By Steven DiJoseph

Although Bausch & Lomb and the FDA have not ordered a recall of any contact lens solutions other than ReNu With MoistureLoc, the continued spread of Fusarium keratitis cases around the globe raises serious questions as to the safety of these products in general.

Since the fungal infection at the center of the current problem is relatively rare, experts are troubled by spikes in its occurrence in Asia (Singapore and Hong Kong), the United States, and Europe all at the same time.
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Health Canada Issues Warning that Mislabeled Bottles of Sandoz Prednisolone 1% Ophthalmic Suspension Pose a Serious Risk of Eye Damage

Friday, May 5th, 2006

Health Canada has issued a warning to consumers not to use Sandoz Prednisolone 1% USP ophthalmic suspension eye drops because of the possibility that the bottles may mistakenly contain Blue Collyrium another product that raises “potentially serious health risks.”

The problem was discovered when one bottle from one lot of Prednisolone 1% USP ophthalmic suspension eye drops was found to contain Blue Collyrium.
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FDA Announces Conviction of Two Executives for Fraudulently Selling Unapproved Sterilizing Devices that Led to Blindness in 18 Patients

Friday, May 5th, 2006

The FDA is reporting that two executives of AbTox, a Mundelein, Illinois, company have been of “fraudulently selling uncleared surgical sterilizing devices that led to eye damage in eighteen patients, causing them to lose sight in one eye.”

Ross Caputo and Robert Riley were president and CEO and vice-president of regulatory affairs of AbTox when the company received permission “to market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges. The defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of non stainless-steel instruments.”
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