EYEGLASS FRAME HAZARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-26 for EYEGLASS FRAME HAZARD manufactured by Best Way Mfg & Trading Co Ltd.

Event Text Entries

[17887472] 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 I urge your agency to study this situation and that the hazardous eyeglass rim style be withdrawn from the market.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5014537
MDR Report Key1589596
Date Received2010-01-26
Date Added to Maude2010-02-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEYEGLASS FRAME HAZARD
Generic NameEYEGLASS FRAME HAZARD
Product CodeHQZ
Date Received2010-01-26
Device Sequence No1
Device Event Key0
ManufacturerBEST WAY MFG & TRADING CO LTD


Patients

Patient NumberTreatmentOutcomeDate
10 2010-01-26

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