FDA Adverse Event
Injury
Summary report: N
DIO PTR +24V INTRAOCULAR LENS, DIO PTR +24V
MDR report key: 18102246
·
Received November 8, 2023
Report
- Report Number
- MW5147977
- Event Type
- Injury
- Date Received
- November 8, 2023
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Description of Event or Problem · 0
REPORTER CALLED STATING THAT THE IMPLANTED LENS IN HER LEFT EYE HAS NOT WORKED SINCE SHE GOT IT ((B)(6) 2023). IT HAS CAUSED PROBLEMS SINCE FIRST HAVING IT IMPLANTED AND CONTINUES TO CAUSE PROBLEMS WHICH INCLUDE: NOT BEING ABLE TO DRIVE, HAVING TO USE A WALKER FOR BALANCE ISSUES CAUSED BY THE FAILED LENS, BLURRED VISION, RECURRING LEFT EYE INFECTION AND SENSITIVITY TO LIGHT. REPORTER SAYS THAT SHE HAS BEEN TRYING TO GET HELP TO RESOLVE HER EYE ISSUES FROM HER MEDICAL PROVIDER AS WELL AS FROM JOHNSON & JOHNSON BUT NEITHER SEEM TO WANT TO HELP AND SHE IS FRUSTRATED AND DOES NOT KNOW WHAT TO DO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234782 | DIO PTR +24V INTRAOCULAR LENS, DIO PTR +24V | INTRAOCULAR LENS | HQL | JOHNSON & JOHNSON SURGICAL VISION, INC. | ZZA9003 | 3540962241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Other |