inforMED
InjuryQQU

CURESIGHT

Received Jan 16, 2025 · Event occurred Dec 18, 2024

Report MW5164849 · MDR key 21170512

Device

Generic name

Digital Therapy Device For Amblyopia

Manufacturer

Novasight

Model number

CS 100

Patient

5 YR · Male

  • Headache
  • Blurred Vision
  • Visual Impairment
  • Vomiting
  • Eye Pain
  • Headache
  • Blurred Vision
  • Visual Impairment
  • Vomiting
  • Eye Pain

Narrative

Description of Event or Problem

AFTER MY SON USED THE CURESIGHT DEVICE FOR AMBPLEOPIA TREATMENT, HE STARTED EXPERIENCING SEVERE EYE PAIN, BLURRED VISION, AND A POUNDING HEADACHE. HIS VISION GOT WORSE, AND HE BEGAN VOMITING UNCONTROLLABLY. WE REACHED OUT TO HIS OPHTHALMOLOGIST, WHO ADVISED US TO STOP USING THE DEVICE IMMEDIATELY AND REPORT THE INCIDENT. WE ALSO TRIED CONTACTING THE VENDOR, BUT THE ONLY RESPONSE WE GOT WAS FROM AN UNRELATED CALL CENTER THAT REFUSED TO PROVIDE ANY REAL ANSWER.