Light Adjustable Lens (LAL) 60007-0150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818806021491), received between Jun 18, 2024 and Sep 25, 2026 — classified as 8 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Visual Disturbances

  MAUDE report 50905982 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens+ (LAL+) was explanted from the left eye due to the patient's dissatisfaction with their near vision. No additional information has been provided.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50807901 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +15.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +15.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24138047 ↗
• InjuryJul 10, 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), +15.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22469381 ↗
• InjuryMay 28, 2025Adverse 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), +15.0D) WAS EXPLANTED DUE TO DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22101340 ↗
• InjuryMay 16, 2025Adverse 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), +15.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION.

  Patient problems: Blurred Vision

  MAUDE report 22040072 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS + (LAL+, (B)(6), +15.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO UNHAPPINESS WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 20880707 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +15.0D) A POSTERIOR CAPSULE TEAR WAS NOTED. THE LAL+ WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/21/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19562819 ↗