Z-1257-06

Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water...

Name: Z-1257-06 Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water...
Creator: Hebron International, Inc.
Published: 2006-05-10
License: https://open.fda.gov/license/

Hebron International, Inc. / initiated 2006-05-10 / Terminated

FDA source

Hebron International, Inc. began a recall of Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology... on 2006-05-10. The reason FDA records is "Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1257-06
Status: Terminated
Initiated: 2006-05-10
Posted: 2006-07-26
Terminated: 2012-07-25
Recalling firm: Hebron International, Inc.
Product: Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
FDA root cause: Other
Action: Consignees were notified by certified mail on 05/22/2006.
Quantity in commerce: 334,187 lenses
Distribution: Nationwide
Product codes and lots: All lots

Product code LPL

K051477Class IIMigwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic)Mi Gwang Contact Lens Co., Ltd. / cleared 2006-03-10

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)