FDA.reportPublic FDA data

MAUDE MDR 5064219

MDR report key
5064219
Report number
MW5056044
Event key
0
Event type
3
Date of event
2009-08-21
Date received
2015-09-01
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
1EYE GLASSESEYE GLASSESNAHQG* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-010

Event Narratives#

D

Patient 1

I WAS PRESCRIBED EYE GLASSES TO CORRECT A SMALL DEGREE OF MYOPIA. UNLIKE DRUG PRESCRIPTIONS, NO WARNING LABEL WAS INCLUDED WITH THIS PRESCRIPTION. I LATER FOUND OUT THAT THE EYE GLASSES LIMIT PERIPHERAL VISION AND ARE KNOWN TO ACTUALLY WORSEN THE SYMPTOMS OF MYOPIA OVER TIME. I HAVE STOPPED WEARING MY EYE GLASSES AND BEGUN TO LIMIT ACTIVITIES WHICH HARM MY VISION SUCH AS COMPUTER USAGE AND MY VISION HAS SLOWLY BEGUN TO RETURN TO WHAT IT ONCE WAS.