Lens, Contact (rigid Gas Permeable), Extended Wear
Ophthalmic · 21 CFR 886.5916
Recent MDR events
21 adverse event reports on file
- EUCLID MAX ORTHOKERATOLOGY CONTACT LENSOct 10, 2025InjuryEuclid Vision Corporation3014175039-2025-00001
- EUCLID MAX ORTHOKERATOLOGY CONTACT LENSJan 10, 2023InjuryEuclid Vision Corporation3014175039-2023-00001
- EUCLID MAX ORTHOKERATOLOGY CONTACT LENSDec 22, 2022InjuryEuclid Systems CorporationMW5113998
- I KONE - F60Mar 11, 2021InjuryParagon Vision Sciences, Inc.2020433-2021-00018
- RIGID GAS PERMEABLE CONTACTSJan 24, 2020MalfunctionArt Optical Contact LensMW5092506
- PARAGON CRT CONTACT LENSMay 10, 2019InjuryParagon Vision Sciences, Inc.2020433-2019-00012
- PARAGON CRT100 CONTACT LENSApr 29, 2019InjuryParagon Vision Sciences, Inc.2020433-2019-00011
- ORTHOKERATOLOGY CONTACT LENSESDec 11, 2018Injury2020433-2018-00010
- MENICON Z RIGID GAS PERMEABLE LENSDec 26, 2012OtherMenicon Co. Ltd.9614761-2012-00002
- MENICON EX-Z RIGID GAS PERMEABLE LENSFeb 7, 2012OtherMenicon Co. Ltd.9614761-2012-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
20 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
X-cel Specialty Contacts
DULUTH, GA, US
Paragon Vision Sciences, Inc.
Gilbert, AZ, US
Menicon Co. Ltd.
NAGOYA Aichi, JP
Bausch & Lomb Incorporated
Rochester, NY, US
Art Optical Contact Lens, Inc.
Walker, MI, 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
6 premarket approvals for this product code
- Menicon Co, Ltd.Jul 11, 2000
P990018 · MENICON Z RIGID GAS PERMEABLE CONTACT LENS
- Menicon Co, Ltd.Sep 1, 1989
P880098 · MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
- Ciba Vision CorporationJun 23, 1989
P890020 · FLUOROCON TM-60
- CooperVision, Inc.Dec 31, 1987
P870024 · FLUOROPERM RGP CONTACT LENSES
- Bausch & LombNov 30, 1987
P860022 · BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Paragon Optical Co.Dec 31, 1986
P850038 · PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN