Z-0907-04

Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40

Name: Z-0907-04 Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
Creator: Allergan Medical Optics Inc
Published: 2004-03-29
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2004-03-29 / Terminated / root cause: packaging

FDA source

Allergan Medical Optics Inc began a recall of Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40 on 2004-03-29. The reason FDA records is "The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0907-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2004-11-04
Recalling firm: Advanced Medical Optics, Inc.
Product: Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40
Product code: HQC Unit, Phacofragmentation
Reason for recall: The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
Root cause tag: packaging
FDA root cause: Other
Action: On March 31, 2004, a product notification letter was mailed to all customers via certified mail. The customers were instructed to stop using, quarantine and return all units. They were instructed to complete the Facsimile form provided and faxed it to the AMO Customer Service at 888-324-0021. They were also instructed to call AMO Customer Service at 800-366-6554 to make arrangement to return the product.
Quantity in commerce: 19, 087
Distribution: Distribution was to 67 domestic customers and internationally.
Product codes and lots: Lot # Exp. date 3JR190 10/2006 3KR128 11/2006 3LR100 12/2006 3MR002 12/2006 3MR047 12/2006 3MR048 12/2006 3MR081 01/2007 3MR082 01/2007 4AR045 01/2007 4AR050 01/2007 4AR058 01/2007

Product code HQC

K924235Class IIAmo EliteAllergan Medical Optics / cleared 1992-12-23

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)