OPHTHALAS 532 EYELITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-11-20 for OPHTHALAS 532 EYELITE manufactured by Alcon-irvine Technology Center.

Event Text Entries

[296099] Reporter noted laser shut off during use. Service request message appeared and system could not be restarted. Changed lasers to complete case. Pt was under anesthesia during a forty-five minute delay. No injury, but surgeon felt this could cause a major problem if it recurs. Pt condition reported as guarded.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2003-00220
MDR Report Key498746
Report Source05,07
Date Received2003-11-20
Date of Report2003-10-21
Date of Event2003-10-21
Date Mfgr Received2003-10-21
Date Added to Maude2003-12-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCHARLES DOLBEE
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 761342099
Manufacturer CountryUS
Manufacturer Postal761342099
Manufacturer Phone8175518317
Manufacturer G1ALCON-IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameOPHTHALAS 532 EYELITE
Generic NameLASER PHOTOCOAGULATOR
Product CodeHQB
Date Received2003-11-20
Model Number532 EYELITE
Catalog Number532 EYELITE
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key487494
ManufacturerALCON-IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PKWY. IRVINE CA 92618 US
Baseline Brand NameOPHTHALAS 532 EYELITE
Baseline Generic NameLASER PHOTOCOAGULATOR
Baseline Model No532 EYELITE
Baseline Catalog No532 EYELITE
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2003-11-20

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