Lens, Contact (orthokeratology)
Ophthalmic · 21 CFR 886.5916
Recent MDR events
10 adverse event reports on file
- GLOBAL-OK LENSAug 1, 2023InjuryC & E Gp Specialists, Inc.MW5120477
- UNKNOWN RIGID GAS PERMEABLE CONTACT LENSOct 31, 2012InjuryBausch & Lomb1313525-2012-00037
- BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENSJun 22, 2010InjuryBausch + Lomb1313525-2010-00009
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSMar 23, 2007InjuryBausch & Lomb1313525-2007-00059
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSJan 23, 2006InjuryBausch & Lomb, Inc.1313525-2006-00004
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSJan 23, 2006InjuryBausch & Lomb, Inc.1313525-2006-00005
- ORTHOKERATOLOGY LENSApr 17, 2000InjuryUnkMW1018683
- OK LENS ("NOT CONTACS")Oct 5, 1999InjuryMax Lund O.d.MW1017320
- OK LENSSep 20, 1999OtherUnkMW1017201
- ORTHOKERATOLOGY LENSSep 15, 1999OtherUnkMW1017216
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
46 firms currently registered for this product code
Cler Vision Inc.
Riverside, CA, US
Acculens, Inc.
Golden, CO, US
Art Optical Contact Lens, Inc.
Walker, MI, US
Aurora Gp Lab Inc
Goodyear, AZ, US
Visionary Contact Lens, Inc.
ANAHEIM, CA, US
Visionary Optics, Llc
Front Royal, VA, US
Shinyeyes Inc.
Pasadena, CA, US
Blanchard Vision Corp.
SHERBROOKE Quebec, CA
Hedgefog Research Inc.
San Pedro, CA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Contex, Incorporated
SHERMAN OAKS, CA, US
Contamac Ltd.
ESSEX UK, GB
Bausch & Lomb Incorporated
WILMINGTON, MA, US
Visionary Optics, Llc
Sterling, VA, US
510(k) clearances
6 clearances for this product code
- C&E GP Specialist, Inc.Jan 9, 2019
K183200 · iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- Contamac, Ltd.Jul 13, 2016
K160859 · OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
- Paragon Vision SciencesFeb 28, 2001
K010109 · FLUOROPERM 151-OK, PARAGON HDS 100-OK
- Polymer TechnologyFeb 16, 2001
K003933 · BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
- Paragon Vision SciencesApr 17, 2000
K000224 · FLUROPERM 60-OK, PARAGON HDS-OK
- Airperm, Inc.Apr 8, 1998
K973697 · AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY