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Terminated

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.)

FDA Recall Z-1575-05 · Posted 2005-09-21

Recalling FirmAlcon Research, Ltd
Recall StatusTerminated
Product CodeLQJ
Date Initiated2005-09-02
Date Terminated2007-04-20
Product Quantity75 units

Reason for Recall

Unknown residue noted on suface of flap irrigators incorporated into cusom paks.

Firm Action

Firm notified consignee by letter on 9/2/2005.

Root Cause

Other

Distribution Pattern

Lake Charles, LA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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