PRESCRIPTION SINGLE VISION LENSES
Received Jan 10, 2022 · Event occurred Jan 6, 2022
Report MW5106575 · MDR key 13225344
Device
Generic name
Lens, Spectacle, Non-custom (prescription)
Manufacturer
UnkProduct problems
- Defective Device
Patient
37 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
NOTICED AN ABERRATION IN THE LENSES OF MY DAUGHTERS GLASSES. THEY ARE POLYCARBONATE, SCRATCH RESISTANT, PREMIUM ANTI REFLECTIVE, BLUE LIGHT FILTER ASPHERIC LENSES AND WE HAVE HAD THEM FOR 3 MONTHS. THEY HAVE BEEN WORN LESS THAN 20 TIMES BECAUSE SHE PURCHASED 2 PAIR OF THE SAME GLASSES (DIFFERENT COLOR, SAME FRAME.). WE TOOK THEM TO TARGET OPTICAL WHERE THEY WERE PURCHASED AND WERE TOLD THAT HER NATURAL, UNMASCARAED, NON ARTIFICIAL EYELASHES SCRATCHED THE INSIDE OF THE LENSES. THE IDENTICAL PAIR HAS NO "SCRATCHES". (B)(6). FDA SAFETY REPORT ID# (B)(4).