STORZ COMPUSCAN LT ULT1000

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 1996-10-03 for STORZ COMPUSCAN LT ULT1000 manufactured by Storz Instrument Co..

Event Text Entries

[23400] Pt was implanted with a lens that had been calculated using this ophthalmic a-scan. Post operative eval of the pt found the vision to be 3. 5 to 4. 0 diopters off. Pt's vision is correctable with glasses. No lens exchange is planned at this time.
Patient Sequence No: 1, Text Type: D, B5


[7830061] The user will receive an additional training.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1920664-1996-00689
MDR Report Key43154
Report Source05,06
Date Received1996-10-03
Date of Report1996-09-04
Date of Event1996-08-20
Date Facility Aware1996-08-20
Report Date1996-09-04
Date Reported to Mfgr1996-09-04
Date Mfgr Received1996-09-04
Device Manufacturer Date1993-12-01
Date Added to Maude1996-10-21
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 COMPUSCAN LT
Generic NameOPHTHALMIC A-SCAN
Product CodeHJB
Date Received1996-10-03
Model NumberNA
Catalog NumberULT1000
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age24 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key44124
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address3365 TREE COURT IND BLVD ST LOUIS MO 63122 US
Baseline Brand NameSTORZ COMPUSCAN DIAGNOSTIC ULTRASOUND
Baseline Generic NameULTRASONIC PULSED ECHO IMAGING SYSTEM
Baseline Model NoNA
Baseline Catalog NoULT1000
Baseline ID*
Baseline Device FamilyDIAGNOSTIC ULTRASOUND
Baseline Shelf Life ContainedN
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK903278
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1996-10-03

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