Iowa ophthalmologist warned of infection risk

Monday, 31 July 2006

An ophthalmologist from the University of Iowa says that she warned Bausch & Lomb of the potential infection risk created by its ReNu with MoistureLoc contact lens solution. Dr. Christine Sindt says that despite her warnings, the company took no action to investigate or correct problems with ReNu until cases of the fungal infection Fusarium keratitis began to be noticed among ReNu users. Bausch & Lomb has since issued a worldwide ReNu recall. When ReNu with MoistureLoc was released in November 2004, Dr. Sindt conducted tests on MoistureLoc to assess its safety and effectiveness. She soaked pairs of contact lenses in three solutions—including MoistureLoc—overnight and then gave them to volunteers to wear. After one to two hours, the volunteers removed the lenses and were examined by Dr. Sindt for cornea damage. She then compared her observations with those from exams conducted before the lenses were worn. Dr. Sindt noticed that patients who had used the contact lenses soaked in ReNu had an unusual amount of dead cells on the surface of their corneas and informed Bausch & Lomb of her results. When the company’s public relations director, Fred Edmunds, told Sindt that it had not conducted tests to measure cornea damage over time, she urged it to do so. “I felt like at the time I had done my part to voice my concern,” Dr. Sindt says. Over the next year and a half, more than 100 consumers who used ReNu with MoistureLoc developed Fusarium keratitis symptoms, which forced Bausch & Lomb to issue the ReNu recall. Dr. Sindt believes that a preservative in MoistureLoc may get trapped in the lens, causing cornea damage and vulnerability to infection. “If her theory is true,” fellow ophthalmologist Kenneth Goins says, “the increased preservative in the lens would lead to a breakdown in corneal epithelial surface cells, thereby allowing pathogens direct access to the cornea.” The Food and Drug Administration is currently investigating the link between MoistureLoc and patients who develop Fusarium keratitis symptoms. Inspections of Bausch & Lomb’s Greenville, South Carolina plant in March failed to find a source of contamination that would explain the Fusarium outbreak that led to the ReNu recall.