inforMED
InjuryPJZ

CLARUS

Received Dec 14, 2022 · Event occurred Dec 13, 2022

Report MW5113825 · MDR key 15988150

Device

Generic name

Camera, Ophthalmic, General-use

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

56 YR · Female

  • Headache
  • Blurred Vision
  • Headache
  • Blurred Vision

Narrative

Description of Event or Problem

VISITED OPHTHALMOLOGIST. TECH CONDUCTED EXAM WITH ZEISS CLARUS DEVICE, INVOLVING EXTREMELY BRIGHT FLASH IN RIGHT EYE. IMMEDIATE DARKNESS IN THAT EYE, BLURRED VISION. YELLOW HUED DIMNESS AND BLURRED VISION PERSISTS 90 MINUTES AFTER TEST (IE, NOW). NO INFORMATION OR WARNING GIVEN REGARDING TEST BEFOREHAND, WHICH, IF GIVEN, I WOULD HAVE REFUSED AND DONE DILATION. I DID NOT ALLOW TEST TO BE PERFORMED ON LEFT EYE. COMPARISON TO LEFT EYE DEMONSTRATES SIGNIFICANT AND PERSISTENT DIFFERENCES FROM RIGHT (TESTED) EYE. HEADACHE AS WELL, LOCALIZED TO RIGHT SIDE.