Advanced Medical Optics - Voluntary Recalls

Voluntary Recalls

AMO voluntarily recalled some of their products in 2006 due to a bacterial contamination in the factory process which would have compromised sterility. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. The voluntary and limited recall was caused by an isolated production line problem that affected two of the four production lines in the AMO facility, not because of a formulation issue.

In May 2007, the Centers for Disease Control and Prevention linked AMO MoisturePlus eye solution to Acanthamoeba keratitis infections. AMO announced a recall on Complete MoisturePlus contact lens solution on May 28, 2007. The solution has been linked to cases of an eye infection (keratitis) caused by an organism of the genus Acanthamoeba. The Company was sued in June 2007 by Michael Connolly, who claimed to have developed a keratitis infection after using AMO's MoisturePlus solution.

On June 20, 2009 The Associated Press published an article titled, "Contact Solution Maker Failed to Report Problems". The article states, Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show. The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.

There are still many on-going class action law suits against AMO, claiming the non-sterile contact lens solution has caused injury and complete blindness in some cases.

Read more about this topic:  Advanced Medical Optics

Famous quotes containing the words voluntary and/or recalls:

    Her voluntary fruits, free without fees;
    Torquato Tasso (1544–1595)

    Fear of error which everything recalls to me at every moment of the flight of my ideas, this mania for control, makes men prefer reason’s imagination to the imagination of the senses. And yet it is always the imagination alone which is at work.
    Louis Aragon (1897–1982)