Posts Tagged ‘Acanthamoeba keratitis’

Using contact solution correctly and safely is key to keeping your eyes healthy.  For example, not emptying the solution out of your contact lens case after each use could cause serious injures and even blindness from an infection.  Solutions that are not thrown out after use are essentially “dirty” and can contain various bacteria and micro-organism. Using fresh and clean solution each time reduces the risk of getting eye infections.

The FDA recently published an article on the importance of using contact lens solution correctly and safely.  The article discusses the Dos and Don’ts for contact lens wearers, how to prevent eye infections, and the symptoms of eye infections. In January 2009, the FDA assembled a workshop called “Microbiological Testing of Contact Lens Solution Products,” in collaboration with several eye care professional groups.  The workshop’s goal was to gain consensus on test methods for evaluating contact lens solutions and the development of Acanthamoeba keratitis, a rare but serious eye infection.  The FDA also convened a meeting of its Ophthalmic Device Panel in June 2008, to identify ways to improve contact lens safety. The panel gave updated information about keeping contact lens care products safe. Currently, the FDA is revising the guidance document, which specifically addresses the labeling and directions for proper use of contact lens solutions.

The FDA stresses the importance of not using contact lens solution more than once, not using expired solution, and rubbing and rinsing your contacts thoroughly with clean and fresh solution daily. Failure to use contact lenses and solution correctly can cause eye infections.  Both bacterial and fungal infections can lead to serious consequences, such as permanent loss of sight if left untreated.  Bacterial infections are more common than fungal infections, but fungal infections are much more difficult to diagnose and treat.  If left untreated, fungal infections can cause permanent blindness, sometimes within as little as 24 hours.  Symptoms of eye infections include, but are not limited to: discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, and pain.

The FDA became increasingly aware of the potential danger of not monitoring the safety of contact lens solutions closely after the Advanced Medical Optics’ (AMO) voluntary recall of Complete MoisturePlus contact lens solution.  The Center for Disease Control and Prevention identified a link between Complete MoisturePlus and the onset of Acanthamoeba keratitis, which caused blindness in several Complete MoisturePlus users. AMO speculated that improper handling and shipping of Complete MoisturePlus solutions caused this outbreak.

Some people avoid the hassle and dangers of wearing contact lens by opting to get lasik surgery to permanently correct their visions.  However, even though the technology for lasik surgery has improved over the years, there are still risks involved in lasik surgery.  If you or a loved has been injured by lasik surgery, you may have a lasik malpractice lawsuit and should contact a lasik malpractice lawyer today.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.