| Class 2 Device Recall Alcon Custom Pak | |
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
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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
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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 |
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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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