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Terminated

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).

FDA Recall Z-0427-2007 · Posted 2007-02-15

Recalling FirmCiba Vision Corporation
Recall StatusTerminated
Product CodeLPM
Date Initiated2007-01-11
Date Terminated2008-03-21
Product Quantity11.4 million lenses

Reason for Recall

Reduced Ion Permeability

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033919CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNSCiba Vision Corporation · 2004-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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