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Custom Stable
Valley Contax, Inc. · Model Optimum Extreme (roflufocon E) Clear · UDI-DI 00860011844136
HQD
Prescription
1
510(k) clearances
134
Adverse events
5
Recalls
35
Facilities
Description
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-10 | Boston Foundation For Sight | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
| 2025-06-10 | Boston Foundation For Sight | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
| 2018-07-03 | Alden Optical | Vials labeled for the prescriptions contained incorrect lenses |
| 2018-07-03 | Alden Optical | Vials labeled for the prescriptions contained incorrect lenses |
| 2010-04-20 | Bausch & Lomb Inc | The amount of D&C #6 Dye added to the formulation exceeded specified amounts. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.