Advanced Medical Optics, Inc. (AMO) has issued a recall for one lot of their AMO Healon D Ophthalmic Viscosurgical Device (OVD), 30 mg/mL fill size syringes, which are intended for use during various eye surgery procedures, such as cataract surgery, secondary intraocular lens implantation, corneal transplant surgery and glaucoma filtration surgery.
Testing of some OVD syringes showed endotoxin levels above the required limit, which could potentially cause eye inflammation or Toxic Anterior Segment Syndrome (TASS) in patients after surgery.
According to the FDA recall notice, some physicians have observed the inflammatory reaction in their patients at the one-day post-operative visit.
Most individuals who develop Toxic Anterior Segment Syndrome have symptoms develop within 12 to 24 hours after a generally uneventful eye surgery. Treatment of TASS generally involves intense topical corticosteroids, which most individuals respond rapidly to.
The syringes were distributed between September 1, 2008 and October 29, 2008. The recall only applies to one lot, labeled with Lot Number UD30654 AMO Healon D Opthalmic Viscosurgical Device.
AMO began sending letters to customers on October 30, 2008, but information about the recall was not posted on the FDA website until December 10, 2008. According to the FDA, the letters sent by AMO included a fax reply form which informed customers about the risk and asked them to stop using and remove all units of AMO Healon D OVD, Lot UD30654 from their inventory.
The action has been classified as a Class 1 recall, which is the most serious type of recall, reserved for situations where continued use of the product posts a reasonable probability of serious injury or death.
Advanced Medical Optics, Inc., which manufactures a number of different eye-related products, faced harsh criticism following a May 2007 contact lens solution recall involving their Complete MoisturePlus consumer product. That recall was issued after use of the contact lens solution was linked to an increased risk of a serious and potentially blinding eye infection known as Acanthamoeba keratitis.
Two months after that major recall, a CDC report suggested that only half of healthy contact lens users were aware of the recall, and less than a quarter were aware of which specific product was involved. Out of 151 individuals interviewed by the CDC, 15 people acknowledged using the Complete MoisturePlus solution during the month before the recall, and 12 were still using the product, unaware that Advanced Medical Optics had issued a recall.
AMO was criticized for not advertising the recall via television, radio or newspapers. They relied only on government bulletins, press releases and the media to inform the public, instead of notifying their customers directly.
Over 100 people have filed Acanthamoeba keratitis lawsuits against AMO as a result of the May 2007 Complete MoisturePlus recall.