HMTClass II

Drape, Patient, Ophthalmic

General, Plastic Surgery · 21 CFR 878.4370

MDR events19All time

Recalls1All time

Registered firms58Currently listed

510(k) clearances7All time

Recent MDR events

19 adverse event reports on file

EYE-PAK OPHTHALMIC DRAPEMar 12, 2025
InjuryAlcon Research, Llc - Houston1644019-2025-00657
ADHERUS AUTOSPRAY ET DURAL SEALANTAug 3, 2022
MalfunctionStryker Cmf Us0008010177-2022-00026
EYE-PAK OPHTHALMIC DRAPEMar 18, 2020
InjuryAlcon Research, Llc - Houston1644019-2020-00151
EYE-PAK OPHTHALMIC DRAPEMar 18, 2020
InjuryAlcon Research, Llc - Houston1644019-2020-00152
VISEO SURGICAL DRAPEJan 7, 2020
InjuryAlcon Research, Llc - Houston1644019-2020-00021
DRAPE OPHTHALMIC INCISE W/POUCHAug 9, 2017
InjuryQuiroproductos De Cuauhtemoc S. De R.l. De C.v.1423537-2017-00120
EYE-PAK OPHTHALMIC DRAPEApr 7, 2017
InjuryAlcon Research, Ltd. - Houston1644019-2017-00326
CATARACT CUSTOM DRAPE PACKJun 18, 2014
MalfunctionAlcon Laboratories, Inc3893439
ARMATECJan 30, 2014
MalfunctionMicrotek Medical, Inc.3605188
CUSTOM PAKOct 30, 2008
InjuryAlcon - Houston1644019-2008-00032

Event type breakdown

Injury9

Malfunction7

Other3

Most-reported manufacturers

Alcon Research, Llc - Houston4 Allegience3 Medical Concepts Development, Inc.3 Alcon - Houston1 Alcon Laboratories, Inc1 Alcon Research, Ltd. - Houston1 Alcon-houston1 Microtek Medical1

Recalls

1 recall events for this product code

Alcon Research, Ltd.
TerminatedSep 24, 2014
eye-pak 7407 Tray Support Cover REF 8065740745
The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.
Z-2694-2014 · View FDA record ↗

Registered firms

58 firms currently registered for this product code

510(k) clearances

7 clearances for this product code