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U.S. Department of Health and Human Services

Class 1 Device Recall Healon D

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  Class 1 Device Recall Healon D see related information
Date Initiated by Firm October 29, 2008
Date Posted December 10, 2008
Recall Status1 Terminated 3 on February 21, 2012
Recall Number Z-0343-2009
Recall Event ID 50179
PMA Number P880031 
Product Classification ophthalmic viscosurgical device - Product Code LZP
Product AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
Code Information Lot Number: UD30654
Recalling Firm/
Manufacturer		 Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana CA 92705
For Additional Information Contact John Smith
714-247-8691
Manufacturer Reason
for Recall		 Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.
FDA Determined
Cause 2		 Process design
Action On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form. The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions: (1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654. (2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days. The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.
Quantity in Commerce 1450
Distribution Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LZP and Original Applicant = ABBOTT MEDICAL OPTICS INC
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