ClearanceBrief
Recall Z-1257-06 ยท LPL Lenses, Soft Contact, Daily Wear

Hebron International, Inc.

Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.

DateJul 26, 2006 (initiated May 10, 2006)
StatusTerminated
ReasonContact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
Root causeOther
ActionConsignees were notified by certified mail on 05/22/2006.
Quantity334,187 lenses
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K051477MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
Mi Gwang Contact Lens Co., Ltd., Mar 10, 2006