FDA Adverse Event
Injury
Summary report: N
LIGHT DELIVERY DEVICE (LDD)
MDR report key: 22194530
·
Received June 12, 2025
Report
- Report Number
- 3012712027-2025-00177
- Event Type
- Injury
- Date Received
- June 12, 2025
- Date of Event
- November 27, 2024
- Report Date
- June 12, 2025
- Manufacturer
- RXSIGHT INC.
- Product Code
- PZK
- UDI-DI
- 00818806020029
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE MANUFACTURER'S REFERENCE #: (B)(4).
Description of Event or Problem · 0
A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2024, 1 WEEK FOLLOWING THE LOCK-IN LIGHT TREATMENT, THE PATIENT WAS PRESCRIBED ANTIVIRAL MEDICATION TO TREAT HERPES ZOSTER OPHTHALMICUS (HZO). TOPICAL STEROID WAS SUBSEQUENTLY ADDED TO TREAT AN ASSOCIATED UVEITIS. SYMPTOMS WERE RESOLVED ON (B)(6) 2025, AND THE PATIENT PROCEEDED TO COMPLETE THE FINAL LOCK-IN LIGHT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2032962 | LIGHT DELIVERY DEVICE (LDD) | LIGHT DELIVERY DEVICE (LDD) | PZK | RXSIGHT INC. | 61002 | 00818806020029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |