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Man Diagnosed with Fusarium Keratitis After Using ReNu with MoistureLoc Files Lawsuit Against Bausch & Lomb

May 29, 2006 | Parker & Waichman, LLP Announces It Has Filed Suit on Behalf of Man Diagnosed With Fusarium Keratitis in Left Eye After Using ReNu With MoistureLoc Contact Lens Solution

Victim Underwent Cornea Transplant, Lensectomy, Capsulectomy, Iris Removal and Multiple Flush-Out Surgeries on Left Eye, Awaits FDA Approval for Iris Transplantp> Parker & Waichman, LLP announces that it has filed a suit against Bausch & Lomb, Inc. on behalf of a 53-year-old man who was diagnosed with Fusarium keratitis in his left eye after using ReNu with MoistureLoc. As a result of the infection, the injured man underwent a corneal transplant after several invasive surgical procedures to remove the infection failed. He is currently awaiting FDA approval for an iris transplant. The suit was filed yesterday in the Supreme Court of the State of New York in Onondaga County.

On April 10, 2006 the FDA and the CDC issued public health warnings concerning serious fungal infections associated with contact lens solution use. The CDC stated that it had interviewed 30 patients suspected of having fungal keratitis. Of these 30 patients, 28 wore soft contact lenses and 26 used a Bausch & Lomb ReNu contact lens solution in the month prior to the fungal infection diagnosis. On April 13, 2006 Bausch & Lomb, Inc. recommended that consumers switch to another lens care solution and asked all retailers to remove U.S.-manufactured ReNu with MoistureLoc from their shelves. On May 2, 2006 the CDC announced that the number of confirmed fungal infections rose to 88 cases. Just three days later, on May 5, 2006, the CDC revised the number of confirmed cases to 102.

On May 12, 2006 the CDC made another upward revision in the number of confirmed fungal eye infections to 122 cases. On May 15, 2006 the FDA issued a press release stating: “Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide.’’ The recall followed Bausch & Lomb’s conclusion that the product’s formula may increase the risk of fungal eye infections in certain situations. Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus, preventing the disinfectant in the product from killing the fungus.

The injured party, who resides in upstate New York, was diagnosed with a fungal infection in his left eye in October 2005, and was referred to a cornea specialist at Columbia Presbyterian in New York City. The specialist performed a corneal confocal microscope exam and several biopsies, which confirmed the diagnosis of Fusarium keratitis. The specialist notified the plaintiff that a cornea transplant would be necessary. Because the transplant procedure could not be performed until the infection was under control, the victim was prescribed voriconazole, a potent anti-fungal medication, which had to be administered approximately every 2 hours, 24 hours each day, over the course of several months. After the infection appeared to be under control, the cornea transplant procedure was performed. During the cornea transplant surgery, additional signs of the fungal infection were discovered. This later led to approximately 5 flush-out surgeries, which involved accessing the back of the left eye through an incision in order to remove additional evidence of the Fusarium fungal infection. The infection returned following the flush-out surgeries, requiring the victim to undergo a lengthy and invasive surgery with the following procedures performed on his left eye: lensectomy, capsulectomy, removal of the iris, removal of vitreous fluid, and removal of the fungal infection. The victim is left with only 15% vision in his left eye and is currently awaiting FDA approval for an iris transplant.

Fungal keratitis is a severe infection of the cornea. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4 — 21 per 10,000 soft contact lens users. Fungal keratitis is a condition more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications. Patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person.

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