DISPOSABLE VITRECTOMY LENS: WIDE VIEW 1284.GD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for DISPOSABLE VITRECTOMY LENS: WIDE VIEW 1284.GD manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.

MAUDE Entry Details

Report Number1222074-2019-00032
MDR Report Key9181458
Date Received2019-10-11
Date Added to Maude2019-10-11
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, 3214VN
Manufacturer CountryNL
Manufacturer Postal3214 VN
Manufacturer G1D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
Manufacturer StreetSCHEIJDELVEQEG 2
Manufacturer CityZUILAND, 3214VN
Manufacturer CountryNL
Manufacturer Postal Code3214 VN
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDISPOSABLE VITRECTOMY LENS: WIDE VIEW
Generic NameVITRECTOMY CONTACT LENS, SINGLE-USE
Product CodeHJK
Date Received2019-10-11
Catalog Number1284.GD
Lot Number2000405159
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, 3214VN NL 3214 VN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-11

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