AMO Healon D OVD Recall Side Effects. The lawyers and attorneys at our firm are offering free consultations to anyone injured by a contaminated Healon D Ophthalmic Viscosurgical Device (OVD) made by Advanced Medical Optics (AMO). AMO Healon D devices were recalled in December 2008 due to a contamination problem.
The action was deemed a Class I recall – the most serious type – by the Food & Drug Administration (FDA).If you underwent eye surgery that involved the use of an AMO Healon D device, and suffered from serious eye inflammation, or a condition called Toxic Anterior Segment Syndrome (TASS), you may be entitled to compensation.
We urge you to contact one of our AMO Healon D OVD recall lawyers right away to discuss the legal remedies available to you.
In the past, AMO – which makes a variety of eye care products has issued several other recalls because of contamination issues. In fact, between 2006 and 2007, AMO issued two such recalls of its Complete MoisturePlus products. In some cases, these shoddy products caused serious eye infections, leading to permanent injury for some victims.
The AMO Healon D OVD recall, coming so close to the Complete MoisturePlus recalls, indicates that there are serious problems with AMO’s manufacturing practices. These problems are putting patients who use AMO products at an unacceptably high risk of injury. Our AMO Healon D OVD recall lawyers intend to make sure this company is held accountable for its negligence.
AMO Healon D OVD Recall
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
- 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. An endotoxin is a toxic substance bound to a bacterial cell wall and released when the bacterium ruptures or disintegrates.
According to the recall notice, some physicians who use a Healon D OVD observed an inflammatory reaction in their patients at the one-day post-operative visit. The FDA said the contaminated AMO Healon D devices put patients at risk of serious eye inflammation and TASS.
TASS is an acute inflammation of the front third of the eye that includes the structures in front of the vitreous humour: the cornea, iris, ciliary body and lens. Most patients with TASS will develop symptoms within 12 to 24 hours of the surgery.
The AMO Healon D OVD recall involved one lot of 30 mg/mL fill size syringes, labeled with “Lot Number UD30654 AMO Healon D Opthalmic Viscosurgical Device. The device was manufactured from September 1, 2008 through September 30, 2008 and distributed from September 1, 2008 through October 29, 2008.
AMO began sending letters notifying its customers of the Healon D OVD recall on October 30, 2008
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.
The AMO Healon D OVD recall was not the first time that one of the company’s products was recalled for contamination problems.On May 26, 2007, the FDA announced a Class I recall of AMO Complete MoisturePlus contact lens solution after it was tied to several cases of Acanthamoeba keratitis.
This disorder is a rare parasitic eye infection that can lead to vision loss. Dozens of people sustained life-altering injuries as a result of tainted Complete MoisturePlus.
Less than a year earlier, on November 22, 2006, 2.9 million packets of AMO Complete MoisturePlus Multi-Purpose contact lens solution and Active Packs were recalled because of bacterial contamination. The recall included 183,000 Complete MoisturePlus units sold in the United States.
The contamination became apparent after a retailer in Japan complained that some bottles of lens cleaner appeared to be damaged. AMO traced the contaminated units to a plant in China and found that Ralstonia bacteria had compromised the disinfectant in the solution and were eating away at the oxygen in the bottles.
Need Legal Help Regarding AMO Healon D OVD?
If you or someone you know suffered from serious eye inflammation, TASS, or any other injury related to a contaminated AMO Healon D OVD device, you have valuable legal rights. Please fill out our online form or call 1-800 YOURLAWYER (1-800-968-7529) right away to discuss your case with one of our AMO Healon D OVD recall lawyers.