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Light Adjustable Lens (LAL) 60007-0120Recalls & reported problems

Rxsight, Inc. · LAL+, Light Adjustable Lens, Sterile, Packaged, 12.0 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806021453), received between May 14, 2025 and Jan 9, 2026 — classified as 2 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: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Blurred Vision2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +12.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH VISION.

    Patient problems: Blurred Vision

    MAUDE report 24021690 ↗
  • InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +12.0D) WAS EXPLANTED DUE TO BLURRY VISION. A LAL (SN (B)(6), +11.0D) WAS IMPLANTED AS A REPLACEMENT.

    Patient problems: Blurred Vision

    MAUDE report 22019125 ↗

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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