FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1257-06
- 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.
- Status
- Terminated
- Initiated
- 2006-05-10
- Posted
- 2006-07-26
- Terminated
- 2012-07-25
- Reason
- Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
- Root cause
- Other
- Action
- Consignees were notified by certified mail on 05/22/2006.
- Quantity
- 334,187 lenses
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K051477"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 3005746624
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28