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Light Adjustable Lens (LAL) 60007-0260Recalls & reported problems

Rxsight, Inc. · LAL+, Light Adjustable Lens, Sterile, Packaged, 26.0 Diopter · Class 3 · Implant

All models of Light Adjustable Lens (LAL) (33)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806021682), received between Oct 24, 2024 and Sep 28, 2026 — classified as 5 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5

Patient problems

  • Blurred Vision3
  • Visual Disturbances3
  • Capsular Bag Tear2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 50916565 ↗
  • InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS+, ONE OF THE HAPTICS TORE THE CAPSULAR BAG. A VITRECTOMY WAS PERFORMED AND THE LENS WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

    Patient problems: Capsular Bag Tear

    MAUDE report 25375540 ↗
  • InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+). A VITRECTOMY WAS PERFORMED AND A LIGHT ADJUSTABLE LENS WAS SUCCESSFULLY PLACED IN SULCUS DURING THE PROCEDURE.

    Patient problems: Capsular Bag Tear

    MAUDE report 24916743 ↗
  • InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +26.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY DISTANCE VISION AND VISUAL DISTURBANCES. A NEW LAL (SN: (B)(6), +26.0D) WAS IMPLANTED AS A REPLACEMENT.

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 24867705 ↗
  • InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +26.0D) WAS EXPLANTED DUE TO BLURRED VISION AND VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +27.0D) WAS IMPLANTED INTO THE SULCUS.

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 20529067 ↗

Other Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) devices

All Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) devices →

Sources and updates

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