3D OCT-1 MAESTRO
Report
- Report Number
- 2242863-2024-00001
- Event Type
- Injury
- Date Received
- April 15, 2024
- Date of Event
- March 1, 2024
- Report Date
- April 15, 2024
- Manufacturer
- TOPCON CORPORATION
- Product Code
- OBO
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
TOPCON IS IN THE PROCESS OF CONTACTING THE HOSPITAL WHERE THE INCIDENT OCCURRED TO FURTHER INVESTIGATE.
THE INJURED PATIENT PERSONALLY REPORTED TO TOPCON THAT THEY ATTENDED AN EYE EXAM INVOLVING TOPCON'S 3D OCT-1 MAESTRO. UPON RECEIVING A FLASH OF LIGHT FROM THE DEVICE, THE PATIENT REPORTED EXPERIENCING AN EPILEPTIC SEIZURE WHILE IN THE EXAMINATION ROOM. FOLLOWING THE SEIZURE, THE PATIENT DESCRIBES NOT BEING GIVEN FIRST AID OR OFFERED AN AMBULANCE AND INSTEAD BEING INFORMED THAT THE NEXT PATIENT WAS BEING CALLED FOR THEIR EXAMINATION. THE PATIENT CALLED A TAXI TO RETURN HOME, BUT STATES THEY FELL AND FRACTURED THEIR RIBS ON THE ELBOW REST OF THEIR WHEELCHAIR WHILE GETTING INTO THE TAXI. THE PATIENT FURTHER REPORTS EXPERIENCING SEIZURES SEVERAL TIMES A DAY FOLLOWING THE INCIDENT DURING THE EYE EXAM. THE PATIENT LATER STATED THAT THEY EXPERIENCED HEADACHES AND DIZZINESS FOR TWO DAYS FOLLOWING THE INCIDENT AFTER WHICH TIME THEY CONTACTED THEIR DOCTOR AND WERE INSTRUCTED TO INCREASE THE DOSAGE OF THEIR [UNSPECIFIED] MEDICATION. THE PATIENT WAS NOT HOSPITALIZED AND RESTED UNTIL THE SIDE EFFECTS OF THE SEIZURE SUBSIDED. THE PATIENT ALSO VISITED THE DOCTOR TO EVALUATE THE INJURED RIB AT WHICH TIME IT WAS CONFIRMED TO BE FRACTURED. NO HOSPITALIZATION OCCURRED, BUT THE PATIENT WAS PRESCRIBED PAINKILLERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1469657 | 3D OCT-1 MAESTRO | OPTICAL COHERENCE TOMOGRAPHER | OBO | TOPCON CORPORATION | 470109900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |