Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

AMO recall continues

This article was originally published in The Tan Sheet

Executive Summary

FDA announces Aug. 1 many consumers may not be aware of Advanced Medical Optics Complete MoisturePlus Multipurpose Contacts Lens Solution recall first issued in May. The firm first announced its recall in May due to a potential link between the solution and Acanthamoeba keratitis, a rare eye infection, in soft contact lens wearers (1"The Tan Sheet" June 4, 2007, In Brief). FDA says several cases of the disease have been reported to the Centers for Disease Control and Prevention after the recall was announced...

You may also be interested in...



AMO’s mixed first quarter

Advance Medical Optics' overall eye care sales are flat at $59 million (a 0.5 percent increase) during the firm's fiscal 2008 first quarter, according to a May 1 release. A 24.6 percent drop in multi-purpose solution sales, "reflecting recall-related impacts" (1"The Tan Sheet" Aug. 26, 2007, In Brief), cancelled out a 37 percent increase in other eye care sales, including the U.S. launch of Blink Tears, AMO's first OTC dry eye product, the firm says. Nonetheless, AMO's net sales rose 20.7 percent to $303.7 million during the first quarter - affirming the firm's 2008 expectations for revenues between $1.22 billion to $1.24 billion, according to the release...

AMO recalls Complete MoisturePlus

Advanced Medical Optics recalls the multipurpose contact lens solution after the Centers for Disease Control and Prevention reports a potential link between the product and Acanthamoeba keratitis, a rare eye infection, the Santa Ana, Calif.-based firm announces May 25. AMO says it voluntary initiated a worldwide recall out of "an abundance of caution" in response to reports 46 people had developed AK, 21 of whom used Complete MositurePlus the month prior to symptom onset. AMO adds the current recall is unrelated to reports of the fungal infection Fusarium keratitis that led to Bausch & Lomb's worldwide recall of its ReNu with MoistureLoc contact lens solution in 2006 1("The Tan Sheet," April 17, 2006, p. 5)...

FDA To Ramp Up ASCA Pilot In 2021

A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.

Topics

UsernamePublicRestriction

Register

LL1135544

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel