Z-0427-2007

OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3...

Name: Z-0427-2007 OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3...
Creator: Ciba Vision Corporation
Published: 2007-01-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2007-01-11 / Terminated

FDA source

Ciba Vision Corporation began a recall of OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per... on 2007-01-11. The reason FDA records is "Reduced Ion Permeability". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0427-2007
Status: Terminated
Initiated: 2007-01-11
Posted: 2007-02-15
Terminated: 2008-03-21
Recalling firm: Alcon Laboratories
Product: OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Reduced Ion Permeability
FDA root cause: Other
Action: Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.
Quantity in commerce: 11.4 million lenses
Distribution: Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany
Product codes and lots: All Lots starting with 6644001 through 6721262, with expiration dating of 2011/09 through 2011/11, and Lot numbers: 6626127, 6636101, 637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, 6642132 and 6643080, all with expiration dating of 2011/08.

Product code LPM

K033919Class IICiba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsCiba Vision Corporation / cleared 2004-03-12

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)