Z-1575-05

Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1...

Name: Z-1575-05 Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1...
Creator: Alcon Research, Ltd
Published: 2005-09-02
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2005-09-02 / Terminated

FDA source

Alcon Research, Ltd began a recall of 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... on 2005-09-02. The reason FDA records is "Unknown residue noted on suface of flap irrigators incorporated into cusom paks". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1575-05
Status: Terminated
Initiated: 2005-09-02
Posted: 2005-09-21
Terminated: 2007-04-20
Recalling firm: Alcon Laboratories
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.)
Product code: LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Reason for recall: Unknown residue noted on suface of flap irrigators incorporated into cusom paks.
FDA root cause: Other
Action: Firm notified consignee by letter on 9/2/2005.
Quantity in commerce: 75 units
Distribution: Lake Charles, LA
Product codes and lots: Lot numbers: 520522H, 511655H, and 489635H

Product code LQJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)