Class 1 Recall: Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD)

Date Recall Initiated:
October 29, 2008 (Updated December 10, 2008)

Product:
AMO Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes

This product was manufactured from September 1, 2008 through September 30, 2008 and distributed from September 1, 2008 through October 29, 2008.

This recall only involves Lot Number UD30654.

Use:
This 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

Recalling Firm:
Advanced Medical Optics, Inc.
1700 East Saint Andrew Place
Santa Ana, California 92705-4933

Reason for Recall:
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.

Public Contact:
The company may be contacted at 1-714-247-8691.

FDA District:
Los Angeles

FDA Comment:
On October, 30, 2008, AMO began sending recall letters by overnight delivery to their U.S. customers. 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.
• Asked the customers to take the following actions:
  • 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.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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