HJIClass I

Lens, Fundus, Hruby, Diagnostic

Ophthalmic · 21 CFR 886.1395

MDR events13All time

Recalls1All time

Registered firms10Currently listed

510(k) clearances8All time

Recent MDR events

13 adverse event reports on file

GRIESHABER DSP SURGICAL CONTACT LENSJun 29, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00161
GRIESHABER DSP SURGICAL CONTACT LENSJun 27, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00150
GRIESHABER DSP SURGICAL CONTACT LENSJun 26, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00127
GRIESHABER DSP SURGICAL CONTACT LENSJun 23, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00084
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00061
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00062
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00063
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00064
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00066
GRIESHABER DSP SURGICAL CONTACT LENSJun 13, 2023
InjuryAlcon Grieshaber Ag3003398873-2023-00067

Event type breakdown

Injury12

Malfunction1

Most-reported manufacturers

Alcon Grieshaber Ag11 Ebi Medical Systems, Inc.1 Unk1

Recalls

1 recall events for this product code

Volk Optical Inc
TerminatedJul 9, 2015
Lombart 90D Clear with case
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Z-2055-2015 · View FDA record ↗

Registered firms

10 firms currently registered for this product code

510(k) clearances

8 clearances for this product code