Advanced Medical Optics (AMO), the Santa Ana California based global eye technology company has recalled one lot of its Healon D Ophthalmic Viscosurgical Device (OVD) as some of the syringes had endoxin levels above the required limit. One legal expert says that the issue may be broader than the company is reporting.

More about the device & the company

AMO's Healon D Ophthalmic Viscosurgical Device is intended for intraocular use as a surgical aid in the following ophthalmic surgical procedures (anterior segment surgery):

• cataract surgery, with or without an intraocular lens
• corneal transplant surgery
• glaucoma filtration surgery, and
• secondary intraocular lens implantation

This isn't the first time AMO has recalled products. In 2007, the company recalled its Complete MoisturePlus contact lens solution because of reports of an eye infection caused by a parasite which was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). The company faces hundreds of lawsuits over the matter.

Class 1 recall

The U.S. Food & Drug Administration (FDA) has labeled the current matter a Class 1 recall, the most serious type of recall which may involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The FDA has stated that some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome (TASS) in patients following surgery.

According to the manufacturer, Lot Number UD30654, 30 mg/mL fill size syringes were manufactured from September 1, 2008 through September 30, 2008 and distributed from September 1, 2008 through October 29, 2008. AMO began sending recall letters by overnight delivery to their U.S. customers at the end of October. The recall letters included a FAX reply form and informed the customers that some physicians observed an inflammatory reaction in their patients at the one-day post-operative visit.

The company told customers to:

• Stop using and remove from their inventory all units of AMO Healon D OVD, Lot UD30654.
• Complete the included FAX form and note the quantities of the product present in their facility to be returned.
• FAX form to AMO Customer Service at 1-714-247-8722 within the next three business days.
• Be alerted that an AMO Customer Service Representative will be contacting them to assist with the return of the product.
• Contact AMO at 1-877-266-4543 if any customers have not yet been contacted.

Legal expert says problem may be more serious

Douglass Kreis, a nationally reknown medical device consumer justice lawyer states: "We believe that there are a significant number of patients who undergo ocular surgeries each month who are exposed to Advanced Medical Optics (AMO) Healon D Ophthalmic Visosurgical Device or therapy delivered by syringe. Though the FDA has issued a notice of recall limited to a few months usage, we believe that the span of time during which product with elevated endotoxin levels was manufactured and supplied may be broader. The symptoms would include post surgery pain and swelling in the affected eye(s) and possibly lead to Toxic Anterior Segment Syndrome (TASS) in patients following surgery."

If you've been injured by AMO's Healon D Ophthalmic Visosurgical Device, contact an experienced products liability attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.