Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufa
FDA device recall Z-1257-06 · posted 2006-07-26 · Terminated
Recall details
- Recalling firm
- Hebron International, Inc.
- Reason for recall
- Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
- Action taken
- Consignees were notified by certified mail on 05/22/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 334,187 lenses
- Distribution
- Nationwide
- Date initiated
- 2006-05-10
- Date posted
- 2006-07-26
- Date terminated
- 2012-07-25
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) (K051477) | Mi Gwang Contact Lens Co., Ltd. | 2006-03-10 |