HQMClass IIImplant
Keratoprosthesis, Permanent Implant
Ophthalmic · 21 CFR 886.3400
MDR events6All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances4All time
Recent MDR events
6 adverse event reports on file
- BOSTON KERATOPROSTHESISApr 2, 2013MalfunctionMassachusetts Eye And Ear Infirmary1222945-2013-00003
- BOSTON KERATOPROSTHESISFeb 1, 2013Massachusetts Eye And Ear Infirmary1222945-2013-00001
- BOSTON KERATOPROSTHESISFeb 1, 2013MalfunctionMassachusetts Eye And Ear Infirmary1222945-2013-00002
- ALPHACORJun 25, 2004InjuryArgus Biomedical Pty Ltd.MW1032447
- ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEAJul 9, 2003MalfunctionArgus Biomedical Pty Ltd, Lions Eye Institute Bldg77002-2003-00001
- OK 3 CONTACT LENSJan 26, 1994Contex, Inc.MW4000079
Event type breakdown
Malfunction3
Unspecified2
Injury1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Massachusetts Eye and Ear Infirmary D/B/A BostonJan 30, 2019
K182986 · Boston Keratoprosthesis, Type I Lucia
- Massachusetts Eye & Ear InfirmaryMay 10, 2013
K121203 · BOSTON KERATOPROSTHESIS OR BOSTON KPRO
- Argus Biomedical Pty, Ltd.Aug 29, 2002
K013756 · ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
- Mackeen Consultants, Ltd.Jan 21, 1992
K915062 · DOHLMAN DOANE KERATOPROTHESIS