FDA Adverse Event Injury Summary report: N

QUANTUM OPTICS SILHOUETTE READERS

MDR report key: 3672535 · Received March 6, 2014

Report

Report Number
MW5034874
Event Type
Injury
Date Received
March 6, 2014
Date of Event
December 15, 2013
Report Date
February 27, 2014
Manufacturer
QUANTUM OPTIC'S
Product Code
HQZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

WHEN I BUMPED INTO SOMETHING WEARING READING GLASSES, I CUT MY FACE IN TWO PLACES NEAR MY LEFT EYE. I AM CONCERNED THAT THIS TYPE OF READING GLASSES, WHICH HAVE PROTRUDING SCREWS AND NUTS ON THE BACK SIDE, COULD CAUSE SUBSTANTIAL EYE DAMAGE IN AN ACCIDENT. I HAVE LOST THE READING GLASSES THAT CAUSED THE INJURY, BUT THINK THEY ARE THE ONES HERE: (B)(6). IF THE IMAGE IS ROTATED YOU CAN CLEARLY SEE THE PROTRUDING SCREWS ON THE BACK OF THE LENSES. I THINK THEY WERE THESE SILHOUETTE P131 GLASSES, AND I DID BUY THEM AT (B)(6). IF NOT IDENTICAL TO THESE, THESE SHOW THE EXACT SAME KIND OF PROTRUDING SCREWS. THE SCREWS PROTRUDE PAST THE NUTS AND HAVE SHARP EDGES. EVEN THE NUTS THEMSELVES, IF THE SCREWS WERE FLUSH WITH THE TOPS OF THE NUTS, ARE SHARP AND PROTRUDE SUBSTANTIALLY PAST THE BACK OF THE LENSES. I ALSO HAVE ANOTHER PAIR OF ILINE BRAND READING GLASSES PURCHASED FROM (B)(6) MADE THE SAME WAY. THESE ARE MARKED"; OUTSIDE OF LEFT TEMPLE: "ILINE"; INSIDE OF RIGHT TEMPLE: "I 017 ONYX EDGE GLOW +2.00 PD 62MM D". I HAVE ALSO SEEN FOSTER GRANT BRAND READING GLASSES AT A (B)(6) PHARMACY THAT ARE MADE THE SAME WAY. I AM CONCERNED THAT SOMEONE IS GOING TO HAVE SUBSTANTIAL EYE INJURY FROM WEARING READING GLASSES WITH THESE SHARP SCREWS STICKING OUT OF THE BACK OF THE LENSES. QUANTUM OPTICS SILHOUETTE READERS P131 (B)(6). PURCHASE DATE: (B)(6) 2013. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
134185 QUANTUM OPTICS SILHOUETTE READERS READING GLASSES HQZ QUANTUM OPTIC'S
134186 FOSTER GRANT READING GLASSES HQZ FOSTER GRANT
134270 ONYA EDGE GLOW READING GLASSES HQZ

Patients

Seq Age Sex Outcome Treatment
1 55 YR Required Intervention