MAUDE MDR 1589596

MDR report key
1589596
Report number
MW5014537
Event key
0
Event type
3
Date received
2010-01-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1EYEGLASS FRAME HAZARDEYEGLASS FRAME HAZARDBEST WAY MFG & TRADING CO LTDHQZ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-01-260

Event Narratives#

D

Patient 1

THIS IS TO BRING TO THE ATTENTION OF THE (B) (4) A SAFETY HAZARD TO THE EYES INHERENT IN THE STYLING MANUFACTURE OF A PARTICULAR STYLE OF EYEGLASS FRAMES. THE HALF RIMLESS EYEGLASS FRAMES THAT I HAD WORN CONTAINED SHORT METAL EXTENSIONS PAST THE TEMPLES OF THE FRAME, WITH THE LENSES THEN HELD IN BY A PLASTIC CORD. THIS APPARENTLY IS A VERY COMMON STYLE OF EYEGLASS FRAMES NOW SOLD BY MANY COMPANIES, AND PURCHASED AND SOLD TO CONSUMERS BY OPTICIANS. THESE FRAMES APPEAR TO BE MANUFACTURED IN (B) (4). (B) (4). ABOUT SIX MONTHS AGO WHILE WEARING MY GLASSES I TRIPPED ON A SLIGHTLY UPLIFTED EDGE ON A SIDEWALK, AS I WAS WALKING BRISKLY TO MY CAR. AS I TOPPLED OVER HITTING THE SIDE OF MY HEAD ON THE PAVEMENT, THE SMALL EXTENSION PAST THE TEMPLE OF THE FRAME IMPALED MY HEAD AND CREATED A GOUGE UNDER MY LEFT EYEBROW JUST ABOVE MY EYELID. IF THE PENETRATION HAD BEEN A QUARTER INCH LOWER, IT WOULD HAVE PENETRATED THE EYE, LIKELY RESULTING IN THE LOSS OF MY EYE. I WAS FORTUNATE. THE WOUND HAS SINCE HEALED. I NOW WEAR AN OLDER MODEL HALF RIMLESS EYEGLASS FRAME WHERE THE TOP OF THE RIM ENDS AT THE HINGE WITH THE TEMPLE. I URGE YOUR AGENCY TO STUDY THIS SITUATION AND THAT THE HAZARDOUS EYEGLASS RIM STYLE BE WITHDRAWN FROM THE MARKET.