Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.
FDA Recall Z-1257-06 · Posted 2006-07-26
Advertisement
Recalling FirmHebron International, Inc.
Recall StatusTerminated
Product CodeLPL
Date Initiated2006-05-10
Date Terminated2012-07-25
Product Quantity334,187 lenses
Reason for Recall
Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
Firm Action
Consignees were notified by certified mail on 05/22/2006.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement