FDA Adverse Event
Injury
Summary report: N
LIGHT ADJUSTABLE LENS (LAL)
MDR report key: 23961121
·
Received January 5, 2026
Report
- Report Number
- 3012712027-2026-00005
- Event Type
- Injury
- Date Received
- January 5, 2026
- Date of Event
- December 9, 2025
- Report Date
- January 5, 2026
- Manufacturer
- RXSIGHT INC.
- Product Code
- PZK
- UDI-DI
- 00818806020685
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HISTORY RECORD FOR THE MANUFACTURING LOT WAS REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. MANUFACTURER REFERENCE #: (B)(4).
Description of Event or Problem · 0
A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE PATIENT HAD 3 LIGHT TREATMENTS WITH MINIMAL CHANGES IN REFRACTION. ON (B)(6) 2025, A LENS REPOSITIONING PROCEDURE WAS COMPLETED, AND THE LAL WAS FLIPPED INTO THE CORRECT ORIENTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20018 | LIGHT ADJUSTABLE LENS (LAL) | LIGHT ADJUSTABLE LENS (LAL) | PZK | RXSIGHT INC. | 60005 | L07-008945 | 00818806020685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |