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Terminated

Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.

FDA Recall Z-0703-03 · Posted 2003-04-01

Recalling FirmCiba Vision Corporation
Recall StatusTerminated
Product CodeLPL
Date Initiated2003-03-17
Date Terminated2004-04-07
Product Quantity29,821 units

Reason for Recall

The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.

Firm Action

The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.

Root Cause

Other

Distribution Pattern

Nationwide, Canada and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003071GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARCiba Vision Corporation · 2000-12-13

Official Source

View FDA Recall →

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

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