Z-0348-2007

Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing...

Name: Z-0348-2007 Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing...
Creator: Advanced Medical Optics, Inc.
Published: 2006-09-15
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2006-09-15 / Terminated / root cause: sterility

FDA source

Advanced Medical Optics, Inc. began a recall of Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only) on 2006-09-15. The reason FDA records is "Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant...". 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-0348-2007
Status: Terminated
Initiated: 2006-09-15
Posted: 2007-03-01
Terminated: 2010-02-17
Recalling firm: Advanced Medical Optics, Inc.
Product: Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)
Product code: LPN Accessories, Soft Lens Products
Reason for recall: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.
Root cause tag: sterility
FDA root cause: Other
Action: Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.
Quantity in commerce: 182,678 units for all US products, 2,943,207 units worldwide
Distribution: Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
Product codes and lots: No US distribution

Product code LPN

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)