STORZ INSIDE MARKING OPTICAL ZONE MARKER 9-800I 8.0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-11-01 for STORZ INSIDE MARKING OPTICAL ZONE MARKER 9-800I 8.0 manufactured by Storz Instrument Co..

Event Text Entries

[32806] During a radial keratotomy enhancement procedure, the ring came off the handle of this instrument.
Patient Sequence No: 1, Text Type: D, B5


[7768202] Instrument could not be evaluated as the customer did not return the entire instrument.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1932180-1996-00097
MDR Report Key46839
Report Source06
Date Received1996-11-01
Date of Report1996-10-04
Date of Event1996-10-03
Date Facility Aware1996-10-03
Report Date1996-10-03
Date Reported to Mfgr1996-10-03
Date Mfgr Received1996-10-03
Date Added to Maude1996-11-07
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 NameSTORZ INSIDE MARKING OPTICAL ZONE MARKER
Generic NameOCULAR MARKER
Product CodeHMR
Date Received1996-11-01
Model NumberNA
Catalog Number9-800I 8.0
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key47649
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address499 SOVEREIGN COURT ST LOUIS MO 63011 US
Baseline Brand NameSTORZ INSIDE MARKING OPTICAL ZONE MARKER
Baseline Generic NameOCULAR MARKER
Baseline Model NoNA
Baseline Catalog No9-800I 8.0
Baseline IDNA
Baseline Device FamilyOCULAR MARKER
Baseline Shelf Life ContainedN
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1996-11-01

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