HNJClass I

Punch, Corneo-scleral

Ophthalmic · 21 CFR 886.4350

MDR events12All time

Recalls1All time

Registered firms78Currently listed

510(k) clearances3All time

Recent MDR events

12 adverse event reports on file

PUNCH DECEMET MEMBRANE KELLYMay 3, 2023
InjuryBausch + Lomb0001920664-2023-70046
MORIA PUNCH D8.00 MMOct 8, 2019
MalfunctionMoria Inc.9165941
PUNCH D9.00MMApr 9, 2015
MalfunctionMoriaMW5042079
STORZ DECEMET KELLY MEMBRANE PUNCHApr 11, 2012
MalfunctionBausch & Lomb, Inc.1920664-2012-00060
MORIA HANNA TREPHINE BLADE 8.0Jul 5, 2007
OtherMoria S.a.2529598-2007-00002
PISTON FOR 7-9 MM BLADESJun 15, 1999
InjuryXomed Surgical Products, Inc.1045254-1999-00007
BARRONJan 13, 1998
MalfunctionKatena Products, Inc.MW1012817
STORZ KELLY DECEMET MEMBRANE PUNCHJan 17, 1997
MalfunctionStorz Instrument Company1932180-1997-00009
STORZ KELLY DECEMET MEMBRANE PUNCHJan 17, 1997
MalfunctionStorz Instrument Co.1932180-1997-00010
STORZ KELLY DECEMET MEMBRANE PUNCHJan 3, 1997
MalfunctionStorz Instrument Co .1932180-1997-00002

Event type breakdown

Malfunction9

Injury2

Other1

Most-reported manufacturers

Storz Instrument Co.3 Bausch & Lomb, Inc.1 Bausch + Lomb1 Katena Products, Inc.1 Moria1 Moria Inc.1 Moria S.a.1 Storz Instrument Co .1

Recalls

1 recall events for this product code

Insight Instruments, Inc.
TerminatedNov 4, 2013
MLS Torpedo Mini-Light Ophthalmic single-port illumination.
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
Z-0144-2014 · View FDA record ↗

Registered firms

78 firms currently registered for this product code

510(k) clearances

3 clearances for this product code