PAN-OCEANIC EYEWEAR STYLE 12413,SILVER FRAME/BLACK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-22 for PAN-OCEANIC EYEWEAR STYLE 12413,SILVER FRAME/BLACK * manufactured by Pan Oceanic Products.

Event Text Entries

[51461] According to attorney user purchased the suspect sunglasses in march 1996. After using them client developed a 1-2 degree burn around her eyes and temporary retinal damage. User had applied a 30 sunblock on her entire face and around her eyes, yet was burned only around her eyes. It is attorney's opinion that the shape of the sunglasses, coupled with the silver wire frames acted to create a mirror effect with the sun and reflected the light directly into user's eyes. None of the stores were currently selling the suspect product nor had the chain received any other similar complaints. Contact with owner, pan oceanic products had determined this company had received no similar complaints. A copy of medical examination on 5/16/96, noted "visual fields show possible defect in periphery of left eye superior; refer to md for further evaluation". Record did not provide any information relative to treatment. Division of opthalmic devices, advised investigator, he has been dealing in sunglass products for at least the last 12 years and has never heard of such a complaint. Devices said such injury does not seem likely and conjectured that possibly user stared directly into the sun which if even for a short time could have caused the reported temporary retinal damage. Devices also conjectured perhaps she had thought she had put sunblock around her eyes but didn't. Because the attorney could not provide investigator with the specific whereabouts of the user, the investigator could not ask her, first hand key questions about this incident. In addition, since no sunglasses are available at the stores, investigator has no way of determining how they were labelled or what types of claims were made relative to their safety. Attorney had no labeling information other than the reported brand name and model number.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001877
MDR Report Key92555
Date Received1997-05-22
Date of Report1997-04-14
Date Added to Maude1997-05-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePAN-OCEANIC EYEWEAR
Generic NameSINGLE EYEGLASS PAIR
Product CodeHQY
Date Received1997-05-22
Model NumberSTYLE 12413,SILVER FRAME/BLACK
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key91409
ManufacturerPAN OCEANIC PRODUCTS
Manufacturer Address15 W 37TH ST NEW YORK NY 10018 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-05-22

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