Z-0129-2011

AMO COMPLETE Multi-Purpose Solution, Formula: 9424x

Name: Z-0129-2011 AMO COMPLETE Multi-Purpose Solution, Formula: 9424x
Creator: Abbott Medical Optics Inc (AMO)
Published: 2010-07-23
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2010-07-23 / Terminated / root cause: sterility

FDA source

Abbott Medical Optics Inc (AMO) began a recall of AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and... on 2010-07-23. The reason FDA records is "The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0129-2011
Status: Terminated
Initiated: 2010-07-23
Posted: 2010-11-02
Terminated: 2011-10-13
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Product code: LPN Accessories, Soft Lens Products
Reason for recall: The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
Root cause tag: sterility
FDA root cause: Pending
Action: AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.
Quantity in commerce: 34,080 units
Distribution: International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
Product codes and lots: Lot Numbers: AH01202, AH01072, AH01223, AH01224, and AH01225.

Product code LPN

K014202Class IIComplete Brand Multi-Purpose SolutionAllergan, Inc. / cleared 2002-02-20

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)