inforMED
MalfunctionHQG

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

Unk

Product 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).