Optimum Extreme roflufocon E
Optimum Extreme roflufocon E is a Class II device made by Contamac Holdings Limited, cleared under FDA 510(k) K180616 on 25 Apr 2018 (3 earlier submissions) and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 00865576000218), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00865576000218 | Date22 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180616 | Date25 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 00865576000218
- FDA 510(k) database K180616
- FDA 510(k) database K161100
- FDA 510(k) database K160859
- FDA 510(k) database K033594
Across registries
- FDA 510(k) K180616 decided 25 Apr 2018 Active
- FDA GUDID UDI-DI 00865576000218 listed 22 Jul 2020 Listed
Recalls
-
- Terminated Z-2982-2018
- Terminated Z-2981-2018
Vials labeled for the prescriptions contained incorrect lenses
Timeline
- Cleared FDA 510(k) K033594
- Cleared FDA 510(k) K160859
- Cleared FDA 510(k) K161100
- Cleared FDA 510(k) K180616
- Recall initiated FDA recalls Z-2982-2018
- Recall initiated FDA recalls Z-2981-2018
- Listed FDA GUDID 00865576000218
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optimum Extreme
- Generic name
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Model / Ref / Catalog
- roflufocon E
- Primary DI / UDI-DI
- 00865576000218
- FDA product code
- HQD, MUW
- GMDN term
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Device class
- Class II
- Regulation number
- 886.5916
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).
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- BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS by Polymer Technology Corp.
- BOSTON(R) 7 - 30(ENFLUFOCON A) by Polymer Technology Corp.
- BostonSight® Specialty Lenses by Boston Foundation For Sight, Inc. D/B/A Bostonsight
- eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K by E&E Optics, Inc.