NAGAHARA NUCLEUS CHOPPER E0578L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-01-22 for NAGAHARA NUCLEUS CHOPPER E0578L manufactured by Bausch & Lomb Surgical.

Event Text Entries

[173722] During an ophthalmic procedure, this instrument broke. There was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1999-00003
MDR Report Key207576
Report Source05,06
Date Received1999-01-22
Date of Report1998-12-15
Date of Event1998-12-15
Date Facility Aware1998-12-15
Report Date1998-12-15
Date Reported to Mfgr1998-12-15
Date Mfgr Received1998-12-15
Date Added to Maude1999-01-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNAGAHARA NUCLEUS CHOPPER
Generic NameNUCLEUS CHOPPER
Product CodeHNQ
Date Received1999-01-22
Model NumberNA
Catalog NumberE0578L
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key201480
ManufacturerBAUSCH & LOMB SURGICAL
Manufacturer Address499 SOVEREIGN CT. ST LOUIS MO 63011 US
Baseline Brand NameNAGAHARA NUCLEUS CHOPPER
Baseline Generic NameOPHTHALMIC HOOK
Baseline Model NoNA
Baseline Catalog NoE0578L
Baseline IDNA
Baseline Device FamilyNUCLEUS CHOPPER
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1999-01-22

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