FDA Adverse Event
Injury
Summary report: N
LIGHT ADJUSTABLE LENS (LAL)
MDR report key: 12565662
·
Received October 1, 2021
Report
- Report Number
- 3012712027-2021-00058
- Event Type
- Injury
- Date Received
- October 1, 2021
- Report Date
- October 1, 2021
- Manufacturer
- RXSIGHT, INC.
- Product Code
- PZK
- UDI-DI
- 00818806020104
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 9/2/2021. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ISSUES WERE NOTED. THE EXPLANTED LENS WAS RETURNED FOR EVALUATION. THE LENS WAS CUT INTO MULTIPLE FRAGMENTS. VISUAL AND OPTICAL TESTING NOTED AN AMBIENT ZONE IN THE CENTER OF THE OPTIC, WHICH IS INDICATIVE OF INADVERTENT EXPOSURE TO AMBIENT UV LIGHT.
Description of Event or Problem · 1
THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 9/2/2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459493 | LIGHT ADJUSTABLE LENS (LAL) | LIGHT ADJUSTABLE LENS (LAL) | PZK | RXSIGHT, INC. | 60005 | L02-001130 | 00818806020104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |