RAY-BAN SUNGLASS PREDATOR W1999

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 1997-01-10 for RAY-BAN SUNGLASS PREDATOR W1999 manufactured by Bausch & Lomb Inc..

Event Text Entries

[40559] Customer alleged an injury involving his sunglasses when he struck his face on a shopping cart rack.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643383-1997-00001
MDR Report Key61917
Report Source04,05
Date Received1997-01-10
Date of Report1997-01-09
Date of Event1996-04-05
Date Mfgr Received1996-12-12
Date Added to Maude1997-01-15
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
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameRAY-BAN SUNGLASS
Generic NameSUNGLASS
Product CodeHQY
Date Received1997-01-10
Returned To Mfg1996-05-02
Model NumberPREDATOR
Catalog NumberW1999
Lot NumberNA
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key62257
ManufacturerBAUSCH & LOMB INC.
Manufacturer Address5335 CASTROVILLE RD SAN ANTONIO TX 78227 US
Baseline Brand NameRAY-BAN SUNGLASSES
Baseline Generic NameSUNGLASSES
Baseline Model NoPREDATOR
Baseline Catalog NoW1999
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-01-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.