MAUDE MDR 5529167

MDR report key
5529167
Report number
MW5061273
Event key
0
Event type
3
Date of event
2014-01-01
Date received
2016-03-24
Adverse event
3
Product problem
0
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
1PHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS FPHILLIPS 70F SHADE 3 GLASSES GLASSWORKING SAFETY GLASSES GREEN IR SHADE 3 LENS FPHILLIPSHOY* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-240

Event Narratives#

D

Patient 1

I USED PHILLIPS SAFETY GLASSES SHADE 3 FOR LAMPWORKING GLASS FOR ALMOST 2 YEARS. DURING THAT TIME MY EYES WOULD DRY OUT CONSTANTLY AND I WOULD GET HEADACHES. I DECIDED TO DO SOME RESEARCH AND FOUND GLASSES THAT OTHER LAMPWORKERS LOVED. AFTER I SWITCHED TO THE NEW GLASSES MY EYES FELT MUCH BETTER. HOWEVER, TO THIS DAY MY EYES FEEL LIKE THEY GET TIRED AND DRY OUT EASIER. IN ADDITION THEY SEEM MORE LIGHT SENSITIVE. AFTER SWITCHING TO THE NEW GLASSES, THE LAMPWORKING COMMUNITY BECAME AWARE THAT THE PHILLIPS GLASSES WERE NOT SUFFICIENT. PEOPLE FROM PHILLIPS HAVE TOLD LAMPWORKERS SEVERAL THINGS INCLUDING THAT FAULTY OR EXPERIMENTAL GLASS HAD BEEN USED TO MAKE LENSES FOR THE TIME BEING. A WELL KNOWN PROFESSIONAL IN THIS FIELD, (B)(6), TOOK A PAIR OF THE PHILLIPS LENSES AND ANALYZED THEM. THERE IS A LAYER THAT IS ONLY 2MM THICK THAT NEEDS TO BE 2.7MM THICK TO OFFER THE RIGHT AMOUNT OF COVERAGE. COUNTLESS LAMPWORKERS HAVE HAD THEIR EYES AFFECTED BY THIS. PLEASE HELP! THE 70 F STYLE FRAME COMES IN SMOKE GRAY, EQUIPPED WITH SIDE SHIELDS. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT. I CONTACTED THEM TO LET THEM KNOW ABOUT THE CONCERNS WITH THE GLASSES AND ABOUT A LEADING PERSON IN THE INDUSTRY TESTING THE GLASSES. HE TOLD ME IT WAS ALL "HYPE" AND THAT THEY'VE NEVER SOLD ANYTHING THAT WASN'T SAFE. (B)(4).