HQJClass IIImplant
Implant, Absorbable, (scleral Buckling Methods)
Ophthalmic · 21 CFR 886.3300
MDR events85All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances5All time
Recent MDR events
85 adverse event reports on file
- LABTICIAN RETINAL IMPLANTJun 8, 2016InjuryLabtician Ophthalmics, Inc3002807445-2015-00001
- LABTICIAN RETINAL IMPLANTJun 8, 2016InjuryLabtician Ophthalmics, Inc3002807445-2015-00002
- LABTICIAN RETINAL IMPLANTJun 8, 2016InjuryLabtician Ophthalmics, Inc3002807445-2016-00003
- LABTICIAN RETINAL IMPLANTJun 8, 2016InjuryLabtician Ophthalmics, Inc3002807445-2016-00002
- LABTICIAN RETINAL IMPLANTJun 8, 2016InjuryLabtician Ophthalmics, Inc3002807445-2016-00001
- MIRAGEL SCLERAL BUCKLENov 7, 2007MalfunctionMira, Inc.948929
- Unnamed deviceNov 2, 2006Other1218813-2006-00001
- SCLERAL BUCKLE X 2Sep 22, 2006InjuryMira Inc766481
- LABTICIAN OPHTHALMIA INC.Aug 31, 2004InjuryLabtician Ophthalmic Inc.541320
- MIRAGELSep 20, 2003InjuryMira, Inc.MW1029528
Event type breakdown
Injury54
Malfunction17
Other8
Unspecified6
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Acces Intl. EyewearDec 18, 1989
K896350 · TITAN AIR SPECTACLE FRAME
- Bausch & Lomb Pharmaceutical, Inc.Nov 29, 1988
K884362 · LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
- Labtician Products, Inc.Feb 26, 1988
K875014 · LABTICIAN RETINAL IMPLANTS
- Bcd Products, Inc.Aug 16, 1983
K831773 · MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
- Medical Instrument Research Assoc., Inc.Oct 5, 1976
K760550 · IMPLANT, SILICONE AND TANTALUM