FDA.reportPublic FDA data

MAUDE MDR 7241006

MDR report key
7241006
Report number
MW5075064
Event key
0
Event type
3
Date of event
2018-02-01
Date received
2018-02-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EYEGLASSESLENS, PRESCRIPTION EYE GLASSESUNKHQGI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-020

Event Narratives#

D

Patient 1

I ORDERED TWO SETS OF GLASSES FROM (B)(4). THERE APPARENTLY WAS NO QUALITY CONTROL OF THE GLASSES. THE IMAGE THROUGH BOTH WAS BADLY DISTORTED. I AM CONCERNED ABOUT (B)(4) DISTRIBUTING GLASSES WITH NO QUALITY CONTROL, WHICH COULD HURT PEOPLE'S SIGHT AND MAYBE CAUSE FALLS. I HAVE PHOTOS TAKEN THROUGH THE GLASSES AND WITHOUT THE GLASSES THAT PROVE THE DISTORTION. ZENNI OPTICAL.