FDA Adverse Event
Injury
Summary report: N
CLARUS
MDR report key: 15988150
·
Received December 14, 2022
Report
- Report Number
- MW5113825
- Event Type
- Injury
- Date Received
- December 14, 2022
- Date of Event
- December 13, 2022
- Report Date
- December 13, 2022
- Manufacturer
- CARL ZEISS MEDITEC INC
- Product Code
- PJZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2917915 | CLARUS | CAMERA, OPHTHALMIC, GENERAL-USE | PJZ | CARL ZEISS MEDITEC INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | AUGMENTIN, HIPREX. |