During the summer, a Food & Drug Administration (FDA) advisory panel recommended that contact lens solutions have been subjected to more rigorous testing than what is currently required. The recommendation came after several brands of contact lens alternative, such as Bausch & Lomb's Renu with MoistureLoc, were connected to potentially-blinding eye infections.
Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Touch Lens Option after it was linked to hundreds of cases of Fusarium Keratitis, a rare, but serious illness of the cornea that has the capacity to lead to blindness. Risk factors for illness usually include injury (broadly speaking with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, lens use.
Fungal keratitis can be actually a state more prevalent in warm climates. First-line treatment consists of topical and oral antifungal medications. Patients who don't respond to treatment usually involve surgical intervention, including corneal transplantation. These infections are not transmitted from individual to individual.
The CDC said that it'd interviewed 30 patients suspected of experiencing antibacterial keratitis. Of the 30 patients, 28 wore soft contacts also 26 used a Bausch & Lomb ReNu lens solution from the month prior to the fungal disease diagnosis.
On April 1-3, 2006, Bausch & Lomb, Inc. urged that consumers switch to another lens care solution and asked each of retailers to get rid of U.S. fabricated Renu with [url=http://www.moistureloc.com/]MoistureLoc[/url] in their shelves. On May 2, 2006, the CDC announced that the number of confirmed fungal infections climbed to 88 cases.
On May 12, 2006, the CDC made yet another upward revision in the number of supported fungal eye ailments to 122 cases. On May 15, 2006, the FDA issued a press release saying: "Based on this scientific and epidemiological data suggesting that Renu with MoistureLoc may enhance susceptibility to Fusarium, Bausch and Lomb has decided to permanently remove the Renu with MoistureLoc product globally"
Bausch & Lomb, Inc. and the FDA both confessed that there was a challenge from the chemical properties of Renu with Moisture that prevented the disinfectant within the product from killing the Fusarium fungus. Testing had confirmed the Renu with MoistureLoc solution let a plastic film to produce around the Fusarium fungus which made it resistant to the disinfectant in the item.
Renu with MoistureLoc has been merely one of the lens solutions linked to acute eye ailments. Last year, at the least 21 cases of ailments between the water-borne Acanthamoeba parasite were associated with Advanced Medical Optics (AMO) Entire Moisture Plus solution, prompting the Santa Ana, California-based organization to recall the item.
That AMO recall followed another issued in November 2006, when 2.9 million bundles of AMO Complete Moisture Plus Multi-Purpose contact-lens solution and Active Packs were recalled after many sold in Japan were found to have bacterial contamination. The recall contained 183,000 Complete Moisture Plus units sold in the USA. AMO traced the contaminated units to your plant in China and discovered that Ralstonia bacteria had jeopardized the sap in the solution and were also eating away at the oxygen at the bottles.
Since the outbreaks and recalls, critics of contact lens solution makers have claimed that current testing techniques are not enough to guarantee these products' safety. That argument gained added weight earlier this year when investigators at the Center for Medical Mycology found ReNu with MoistureLoc was unable to resist contamination because the strain of Fusarium accountable for the 2006 outbreak was able to form biofilms.
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Biofilms are clusters of microbes held together by way of a glue-like matrix. This arrangement made the Fusarium excessively resistant to lens solutions and also the human body's own immune system. Unfortunately, contact lens solutions aren't required to be analyzed against germs having the capacity to form biofilms. In fact, Renu with MoistureLoc along with other lens solutions is analyzed against a rare kind of fungus obtained from an individual in Nigeria in the 1970s, which critics say does not have any real-world applicability.
In the instance of the recalled AMO lens solution, there's not any requirement at this time for solutions to be tested against Acanthamoeba.
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