FDA Adverse Event
Injury
Summary report: N
LIGHT ADJUSTABLE LENS (LAL)
MDR report key: 24235002
·
Received February 2, 2026
Report
- Report Number
- 3012712027-2026-00028
- Event Type
- Injury
- Date Received
- February 2, 2026
- Date of Event
- December 5, 2025
- Report Date
- April 30, 2026
- Manufacturer
- RXSIGHT INC.
- Product Code
- PZK
- UDI-DI
- 00818806020593
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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), +15.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES. THE TREATING PHYSICIAN NOTED THERE WAS AN OPACITY UNDER THE ANTERIOR IOL SURFACE. A NEW LAL (SN (B)(6), +14.0D) WAS IMPLANTED AS A REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70872 | LIGHT ADJUSTABLE LENS (LAL) | LIGHT ADJUSTABLE LENS (LAL) | PZK | RXSIGHT INC. | 60005 | L07-006826 | 00818806020593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention |