OPHTHALAS 532 LASER

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 2001-03-29 for OPHTHALAS 532 LASER manufactured by Alcon - Irvine Technology Center.

Event Text Entries

[18136479] Reporter noted the laser fired without dr's filter in place. Dr rec'd back flash. No intervention reported; no injury occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2001-00099
MDR Report Key324779
Report Source05,07
Date Received2001-03-29
Date of Report2001-02-27
Date Mfgr Received2001-02-27
Date Added to Maude2001-04-10
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 Location0
Manufacturer ContactNED LUCE
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 761342099
Manufacturer CountryUS
Manufacturer Postal761342099
Manufacturer Phone8175686410
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameOPHTHALAS 532 LASER
Generic NameLASER PHOTOCOAGULATOR
Product CodeLXS
Date Received2001-03-29
Model Number532 LASER
Catalog Number532 LASER
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key314257
ManufacturerALCON - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PKWY. IRVINE CA 92618 US
Baseline Brand NameOPHTHALAS 532 LASER
Baseline Generic NameLASER PHOTOCOAGULATOR
Baseline Model No532 LASER
Baseline Catalog No532 LASER
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2001-03-29

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