Tainted ReNu, AMO Contact Lens Solutions Prompt FDA Panel to Call for Better Testing

In the past several years, contact lens solutions, including ReNu with MoistureLoc and Advanced Medical Optics Complete MoisturePlus, have been linked to potentially blinding eye infections. Now, a group of Food & Drug Administration (FDA) advisors has recommended that contact lens solutions be subjected to more stringent testing to insure their safety. The panel also recommended that stronger safety warnings be added to the labels of multi-purpose contact lens solutions so that users can know how to avoid contaminating the products.

Contact lens solutions have been subjected to several recalls because of contamination problems that resulted in some users developing serious eye infections. In 2006, Bausch & Lomb issued a worldwide recall of ReNu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. (more…)

Renu with MoistureLoc, Other Contact Lens Solution Recalls Result in FDA Safety Review

Contact lens solutions have been slated for a Food & Drug Administration (FDA) safety review.  The FDA decided to embark on the review after some popular brands of contact lens solutions - including Renu with MoistureLoc - were linked to potentially blinding infections.

An FDA advisory pane is scheduled to meet on June 10 to discuss safety issues surrounding contact lens solutions.  The panel will recommend to the agency whether the solutions should be subjected to new testing methods, or should bear new safety labeling.  The FDA is not bound to follow the recommendations of its advisory panels, but does so in most cases.  (more…)

Bausch & Lomb Renu with MoistureLoc Tests Faulty, New Study Says

Renu with MoistureLoc, the Bausch & Lomb contact lens solution that was responsible for a massive outbreak of Fusarium Keratitis in 2006, was never adequately tested to insure that it was resistant to microbial contamination.   According to a new study conducted by researchers at the Center for Medical Mycology at University Hospitals Case Medical Center in Cleveland, Ohio, the strain of Fusarium used by Bausch & Lomb to test Renu with MoistureLoc was rare and outdated, making tests with the strain a poor indicator of the contact lens solution’s effectiveness.

In 2006, Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control  determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. (more…)

Bausch & Lomb CEO Steps Down, 2 Years after Renu with MoistureLoc Recall

The Bausch & Lomb CEO who oversaw the Renu with MoistureLoc recall debacle has stepped down.  Last year, under Ronald Zarella, who served as Bausch & Lomb CEO since 2001, the company was sold to private equity firm Warburg Pincus of New York City. The sale ended Bausch & Lomb’s almost 70-year run as a publicly traded company.

According to the Rochester Democrat & Chronicle, Zarrella will be replaced by Gerald M. Ostrov, who most recently was group chairman of Johnson & Johnson’s Worldwide Vision Care division. Ostrov left that position in 2006. (more…)

Bausch & Lomb, Still Reeling from ReNu with MoistureLoc Recall, Announces UK Job Cuts

Bausch & Lomb, the maker of recalled ReNu with MoistureLoc Contact Lens Solution, announced that it would be eliminating 250 jobs at one of its plants in the United Kingdom. The job cuts are just the latest bit of bad news for Bausch & Lomb, which has never fully recovered from the 2006 ReNu with MoistureLoc recall.

In 2006, Bausch & Lomb’s ReNu with MoistureLoc Contact Lens Solution was linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006. The Centers for Disease Control (CDC) determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. As of June 30, 2006, the CDC had confirmed 164 cases of Fusarium Keratitis. The same report said that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution.

(more…)

Bausch & Lomb Goes to Court to Force Insurers to Pay for Renu with MoistureLoc Lawsuits

Bausch & Lomb, maker of the recalled Renu with MoistureLoc contact lens solution, is trying to force several insurance companies to help it pay for more than 1,000 lawsuits filed against the company over the tainted product.  That insurance battle is just one example of how the Renu with MoistureLoc recall is still causing problems for the company. Nearly two years later, Bausch & Lomb is still facing serious legal and financial ramifications of the Renu with MoistureLoc disaster.

In 2006, Bausch & Lomb’s Renu with MoistureLoc Contact Lens Solution was  linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled Renu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006. The Centers for Disease Control (CDC) determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. In October of 2006, the Food & Drug Administration (FDA) issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to Renu with MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant.

(more…)

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