inforMED
MalfunctionMWL

RIGID GAS PERMEABLE CONTACTS

Received Jan 24, 2020 · Event occurred Jan 20, 2020

Report MW5092506 · MDR key 9632236

Device

Generic name

Lens, Contact (rigid Gas Permeable)

Product problems

  • Device Markings/Labelling Problem

Patient

61`

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

NEW RIGID GAS PERMEABLE LENS RIGHT CONTACT MARKING VANISHED, I WAS TOLD I HAD TO REDO IT WITH A SHARPIE MYSELF, I DID, TWICE AND IT VANISHES. APPARENTLY, IT COULD BE TATTOOED AND INKED PERMANENTLY (AS ALL MY PREVIOUS PAIRS OF 45 YEARS OF WEARING THEM HAVE BEEN). I AM REQUIRED TO PAY (B)(6) TO SHIP AND COVER THE COST. THESE COST ME (B)(6) OUT OF POCKET AND MY EXPECTATION IS THEY LAST FOR YEARS AND ARE NOT DEFECTIVE. I WOULD LIKE THE VENDOR, ART OPTICAL TO REMEDY THE SITUATION AND COVER THE COST. NEITHER MY EYE DOCTOR OR ART OPTICAL WILL HELP. I CALLED (B)(6) TO COMPLAIN AND THEY SAID THEY COULD NOT TALK TO ME DIRECTLY. PLEASE ADVISE? THANKS FOR YOUR ASSISTANCE. FDA SAFETY REPORT ID # (B)(4).