FDA.reportPublic FDA data

MAUDE MDR 4802297

MDR report key
4802297
Report number
MW5042848
Event key
0
Event type
3
Date of event
2015-05-08
Date received
2015-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OAKLEY BRAND SUNGLASSESSUNGLASSESOAKLEYHQYVALVE Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-220

Event Narratives#

D

Patient 1

SINCE NEW, ANYTIME I WEAR THESE SUNGLASSES, THEY FOG UP QUICKLY AND WITHOUT NOTICE. AT FIRST, I WAS NOT TERRIBLY CONCERNED. HOWEVER, TODAY WHILE DRIVING MY CAR AT APP 55 MPH, THE SUNGLASSES SUDDENLY FOGGED AND COMPLETELY OBSCURED MY FIELD OF VISION. THIS EASILY COULD HAVE CAUSED AN ACCIDENT. I WAS TRAVELING IN THE VEHICLE FOR NEARLY AN HOUR WHEN THIS HAPPENED WITH THE WINDOWS UP AND THE AIR CONDITIONING ON THE LOW SETTING. THERE WERE NO SUDDEN TEMPERATURE OR HUMIDITY CHANGES. I SENT AN EMAIL TO THE MANUFACTURER VIA THEIR WEBSITE. PURCHASE DATE: (B)(6) 2015. (B)(4).