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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Custom Pak

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  Class 2 Device Recall Alcon Custom Pak see related information
Date Initiated by Firm September 02, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on April 20, 2007
Recall Number Z-1575-05
Recall Event ID 33409
Product Classification Lens, Surgical, Laser, Accesssory, Ophthalmic Laser - Product Code LQJ
Product Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
Code Information Lot numbers: 520522H, 511655H, and 489635H
Recalling Firm/
Manufacturer		 Alcon Research, Ltd
6201 South Fwy
Fort Worth TX 76134-2001
Manufacturer Reason
for Recall		 Unknown residue noted on suface of flap irrigators incorporated into cusom paks.
FDA Determined
Cause 2		 Other
Action Firm notified consignee by letter on 9/2/2005.
Quantity in Commerce 75 units
Distribution Lake Charles, LA
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.
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