FDA Adverse Event Other Summary report: N

EYEGLASS FRAME HAZARD

MDR report key: 1589596 · Received January 26, 2010

Report

Report Number
MW5014537
Event Type
Other
Date Received
January 26, 2010
Manufacturer
BEST WAY MFG & TRADING CO LTD
Product Code
HQZ
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 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 I URGE YOUR AGENCY TO STUDY THIS SITUATION AND THAT THE HAZARDOUS EYEGLASS RIM STYLE BE WITHDRAWN FROM THE MARKET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EYEGLASS FRAME HAZARD EYEGLASS FRAME HAZARD HQZ BEST WAY MFG & TRADING CO LTD

Patients

Seq Age Sex Outcome Treatment
1