AMO Recalls Eye Surgery SyringesDec 12, 2008 | Parker Waichman LLP
Advanced Medical Optics (AMO) has announced a Class I recall of its Healon D Ophthalmic Viscosurgical Device (OVD) because of a contamination issue. According to the Food & Drug Administration (FDA), some physicians who used a Healon D OVD during eye surgery observed an inflammatory reaction in their patients at the one-day post-operative visit.
The AMO Healon D OVD recall involved one lot of 30 mg/mL fill size syringes, labeled with "Lot Number UD30654 AMO Healon D Ophthalmic Viscosurgical Device". The device was manufactured from September 1, 2008 through September 30, 2008 and distributed from September 1, 2008 through October 29, 2008.
This is not the first time an AMO product has been recalled for contamination problems. Between 2006 and 2007, AMO issued two such recalls some of its Complete MoisturePlus products. In some cases, these recalled products caused serious eye infections, leading to permanent injury for some victims.
According to the FDA, the AMO Healon D OVD is intended for intraocular use as a surgical aid in the following ophthalmic surgical procedures:
• cataract surgery, with or without an intraocular lens
• corneal transplant surgery
• glaucoma filtration surgery, and secondary intraocular lens implantation
According to the FDA, the AMO Healon D OVD recall was initiated after testing revealed the product had endotoxin levels above the required limit. The FDA said the contaminated AMO Healon D devices put patients at risk of serious eye inflammation and a condition called Toxic Anterior Segment Syndrome (TASS). Severe cases of TASS can cause permanent harm, and if symptoms still are present after six weeks, the eye is not likely to recover.
AMO began sending letters notifying its customers of the Healon D OVD recall on October 30, 2008. However, the recall was not listed on the FDA's website until December 11, 2008. The letters directed customers to stop using the contaminated devices, and to remove all recalled units of the device from their inventories.
The FDA notice said that the AMO Healon D OVD recall was a Class I recall. This is the agency's most serious type of recall, and indicates that a device poses a reasonable probability of serious injury or death.