inforMED
InjuryNFG

OPTOMAP RETINAL SCREENING

Received Mar 12, 2020 · Event occurred Mar 2, 2020

Report MW5093745 · MDR key 9829317

Device

Generic name

Device, Communications, Images, Ophthalmic

Manufacturer

Unk

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

60 YR

  • Headache
  • Red Eye(s)
  • Blurred Vision
  • Dizziness
  • Headache
  • Red Eye(s)
  • Blurred Vision
  • Dizziness

Narrative

Description of Event or Problem

REPORTER STATED THAT SHE HAD A SCREENING DONE ON A OPTOMAP RETINAL SCREENING MACHINE AT THE OPTOMETRIST OFFICE ON (B)(6) 2020. SHE WOKE UP THE NEXT MORNING WITH A SLIGHT HEADACHE, BLURRED VISION ON HER RIGHT EYE AND BOTH EYES WERE RED AND SHE FELT A LITTLE DIZZY. SHE ALSO STATED THAT THIS SYMPTOMS LASTED ALL DAY. PT APPLIED AN EYE DROP TO HER EYES WHICH HELPED A LITTLE. SHE BELIEVE THIS REACTION IS AS A RESULT OF THE SCREENING MACHINE. PT TRIED TO REACH THE DR'S OFFICE TO INFORM HIM ABOUT HER SYMPTOMS BUT THE DR WAS NOT AVAILABLE.