2.5 MM TRIPLE STEP FLARED PHACO NEEDLE (DISPOSABLE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE (DISPOSABLE) manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.

MAUDE Entry Details

Report Number1222074-2020-00019
MDR Report Key9842501
Date Received2020-03-17
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. CHRIS FRYER
Manufacturer StreetSCHEIJDELVEQEG 2
Manufacturer CityZUILAND, NETHERLANDS 3214VN
Manufacturer CountryNL
Manufacturer Postal3214 VN
Manufacturer G1D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
Manufacturer StreetSCHEIJDELVEQEG 2
Manufacturer CityZUILAND, NETHERLANDS 3214VN
Manufacturer CountryNL
Manufacturer Postal Code3214 VN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.5 MM TRIPLE STEP FLARED PHACO NEEDLE (DISPOSABLE)
Generic NamePHACOEMULSIFICATION SYSTEM HANDPIECE TIP, SINGLE-USE
Product CodeHQC
Date Received2020-03-17
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerD.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
Manufacturer AddressSCHEIJDELVEQEG 2 ZUILAND, NETHERLANDS 3214VN NL 3214 VN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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