MAUDE MDR 5489906

MDR report key
5489906
Report number
MW5060794
Event key
0
Event type
3
Date of event
2016-02-27
Date received
2016-03-07
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
1PHILIPS SHADE 3 ACE IRPHILIPS SHADE 3 ACE IRPHILLIPS SAFETY PRODUCTSHQYGB-G3-70F* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-070

Event Narratives#

D

Patient 1

I HAVE A PAIR OF PHILLIPS ACE IR SHADE 3 SAFETY GLASSES FOR BOROSILICATE GLASS BLOWING. THEY ARE SUPPOSED TO BLOCK OUT HARMFUL ORANGE SODIUM FLARE AND THEY FAIL TO DO SO. I NOTICED EXTREME EYE STRAIN AFTER WORKING FOR ANYMORE THAN 4 HOURS AT A TIME AND DECIDED TO LOOK INTO THE ISSUE. I POSTED VIDEO ON A WELL KNOWN GLASS BLOWING FORUM SHOWING MY GLASSES IN ACTION AND I WAS SHOCKED AT THE RESPONSE. PEOPLE ARE TELLING ME MY GLASSES ARE FAILING TO BLOCK OUT THE HARMFUL SODIUM FLARE THAT IS SO DANGEROUS FOR YOUR EYES. IT IMMEDIATELY REMINDED ME OF THE EYE STRAIN I'VE BEEN EXPERIENCING. SINCE THEN, MANY PEOPLE HAVE COME FORWARD WITH FAULTY GLASSES FROM PHILIPS. THERE IS ALSO EVIDENCE THAT PHILIPS HAS USED AN EXPERIMENTAL LENS AFTER RUNNING OUT OF STOCK OF THE ORIGINAL LENS USED. (B)(6 ) THIS IS MY HOME ADDRESS. NO FIRST AID OR MEDICAL ATTENTION RECEIVED. SAFETY GLASSES FOR BLOCKING HARMFUL INFRARED, UV AND SODIUM FLARES WHILE WORKING BOROSILICATE GLASS AT HIGH TEMPS. (B)(6). THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. HAVE YOU CONTACTED THE MANUFACTURER? YES. EXPLANATION: I'VE HEARD NOTHING BACK AFTER CALLING AND EMAILING. (B)(4).