Date Recall Initiated: |
October 29, 2008 |
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Product: |
AMO Healon D Ophthalmic Viscosurgical Device, 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):
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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:
For more information about this recall, please see FDA’s press release at: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01937.html 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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Updated January 5, 2009
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