Lens, Contact, Orthokeratology, Overnight
Ophthalmic · 21 CFR 886.5916
Temporary reduction of myopia or refractive error.
Recent MDR events
39 adverse event reports on file
- EUCLID ORTHOKERATOLOGY (TISILFOCON A) CONTACT LENSES FOR OVERNIGHT WEARMay 7, 2026InjuryEuclid Vision Corporation3014175039-2026-00002
- ACUVUE ABILITI¿ OVERNIGHTApr 22, 2026InjuryMenicon B.v.1000188353-2026-00004
- ACUVUE® ABILITI¿ OVERNIGHTApr 20, 2026InjuryMenicon B.v.1057985-2026-0000026
- PARAGON CRT 100Apr 9, 2026InjuryParagon Vision Sciences, Inc.3013398957-2026-12297
- EUCLID ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEARApr 2, 2026InjuryEuclid Vision Corporation3014175039-2026-00001
- PARAGON CRT DUAL AXISFeb 2, 2026InjuryParagon Vision Sciences.nc.3013398957-2026-12278
- PARAGON CRT 100Jan 8, 2026InjuryParagon Vision Sciences, Inc.3013398957-2026-12273
- ACUVUE ABILITI¿ OVERNIGHTDec 23, 2025InjuryMenicon B.v.1000188353-2025-00009
- ACUVUE® ABILITI¿ OVERNIGHTDec 16, 2025InjuryMenicon B.v.1057985-2025-0000114
- ORTHOKERATOLOGY (ORTHO-K) CONTACT LENSESSep 22, 2025MalfunctionParagon Vision Sciences, Inc.MW5176416
Event type breakdown
Recalls
2 recall events for this product code
- PARAGON VISION SCIENCES, IncOpen, ClassifiedSep 5, 2023
ISee Ortho-K Lens
Manufactured lenses are not covered by existing FDA approval
Z-2515-2023 · View FDA record ↗ - PARAGON VISION SCIENCES, IncOpen, ClassifiedSep 5, 2023
Fargo Ortho-K Lens
Manufactured lenses are not covered by existing FDA approval
Z-2516-2023 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Euclid Vision Corporation
Sterling, VA, US
Contex, Incorporated
SHERMAN OAKS, CA, US
Blanchard Vision Corp.
SHERBROOKE Quebec, CA
Contamac Ltd.
ESSEX UK, GB
X-cel Specialty Contacts
DULUTH, GA, US
Paragon Vision Sciences, Inc.
Gilbert, AZ, US
Visionary Contact Lens, Inc.
ANAHEIM, CA, US
Menicon Co. Ltd.
NAGOYA Aichi, JP
Bausch & Lomb Incorporated
Rochester, NY, US
Cler Vision Inc.
Riverside, CA, US
Shinyeyes Inc.
Pasadena, CA, US
Aurora Gp Lab Inc
Goodyear, AZ, US
Menicon Nect Co., Ltd., Gujo Plant
Gujo Gifu, JP
Menicon Co. Ltd. Global Logistics Center
Yachiyo Chiba, JP
Menicon Co., Ltd., R&d Center
Kasugai Aichi, JP
Menicon Co., Ltd. Techno-station
Kakamigahara Gifu, JP
Bausch & Lomb Incorporated
WILMINGTON, MA, US
Menicon B.v.
Emmen Drenthe, NL
Advanced Vision Technologies
Lakewood, CO, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
5 premarket approvals for this product code
- Tianjin MasterVision Technology Co., Ltd.Aug 5, 2026
P220015 · DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
- Contamac, Ltd.Feb 10, 2026
P240045 · Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
- CooperVision, Inc.Nov 16, 2006
P050031 · PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
- Euclid Vision CorporationSep 29, 2004
P040029 · Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
- Bausch & LombJun 7, 2004
P010062 · EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR