FDA Adverse Event
Injury
Summary report: N
LIGHT ADJUSTABLE LENS+ (LAL+)
MDR report key: 24747875
·
Received March 31, 2026
Report
- Report Number
- 3012712027-2026-00141
- Event Type
- Injury
- Date Received
- March 31, 2026
- Date of Event
- March 4, 2026
- Report Date
- March 31, 2026
- Manufacturer
- RXSIGHT, INC.
- Product Code
- PZK
- UDI-DI
- 00818806021576
- PMA / PMN Number
- P160055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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), +19.5D) WAS IMPLANTED (B)(6) 2024. AFTER THREE ADJUSTMENT LIGHT TREATMENTS, THE PATIENT COMPLAINED OF BLURRY VISION AND REPORTED DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET. AT A FOLLOW UP VISIT, THE LENS WAS OBSERVED TO BE SLIGHTLY DISPLACED. THE PATIENT THEN UNDERWENT A PRK PROCEDURE AND A FOURTH ADJUSTMENT BEFORE THE LENS WAS EXPLANTED. A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809610 | LIGHT ADJUSTABLE LENS+ (LAL+) | LIGHT ADJUSTABLE LENS+ (LAL+) | PZK | RXSIGHT, INC. | 60007 | L08-006012 | 00818806021576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |