Light Adjustable Lens (LAL) 60007-0210Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00818806021606), received between Mar 12, 2024 and Jun 2, 2026 — classified as 24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 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 VISION AFTER ONE LIGHT ADJUSTMENT. A LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT AND THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25362277 ↗
• InjuryMay 6, 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 RIGHT EYE DUE TO BLURRY VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT AND THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY.

  Patient problems: Blurred Vision

  MAUDE report 25095048 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND BLURRY VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25060327 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24879073 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT. DURING THE EXPLANT PROCEDURE, A POSTERIOR CAPSULE TEAR OCCURRED AND AN ANTERIOR VITRECTOMY WAS PERFORMED.

  Patient problems: Blurred Vision; Capsular Bag Tear; Visual Disturbances

  MAUDE report 24720037 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL+ (SN (B)(6), +20.5) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24654895 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND BLURRY VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24654452 ↗
• InjuryMar 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), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 24592290 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24585983 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24508905 ↗
• InjuryFeb 5, 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)) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY DISTANCE VISION. A NEW LAL (SN (B)(6)) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24270021 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +21.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LAL+ (SN: (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24087854 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24067260 ↗
• InjuryDec 3, 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), +21.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION. A NEW LAL (SN: (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23706531 ↗
• InjurySep 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), +21.0D) WAS EXPLANTED FROM THEIR RIGHT EYE DUE TO BLURRY VISION. A STANDARD LAL (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23068761 ↗
• InjuryAug 5, 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), +21.0D) WAS EXPLANTED. A NEW LAL+ (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22723047 ↗
• InjuryJun 13, 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), +21.0D) WAS EXPLANTED DUE TO BLURRY VISION AND DIPLOPIA AND A NEW LAL+ (SN (B)(6), +21.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 22204131 ↗
• InjuryMar 19, 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), +21.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21644928 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT IMPLANTED WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) ON (B)(6) 2023 HAD THE LENS EXPLANTED ON (B)(6) 2024 DUE TO UNHAPPINESS WITH THEIR UNCORRECTED VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21044401 ↗
• InjuryNov 12, 2024Adverse 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), +21.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE TREATING PHYSICIAN OBSERVED THE ISSUE DURING THE POST-OPERATIVE 1-DAY EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664359 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT THE PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +21.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR VISION. THE LAL+ WAS EXPLANTED AND A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20626216 ↗
• InjuryAug 27, 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+, SN (B)(6) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO CHANGE IN REFRACTIVE TARGETS DURING ADJUSTMENT PERIOD FROM DISTANCE TO NEAR. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 07/29/2024.

  Patient problems: Visual Disturbances

  MAUDE report 20082204 ↗
• InjuryJul 5, 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), +21.0D) WAS EXPLANTED DUE TO GLARE SYMPTOMS AND A NEW LAL (SN (B)(6), +20.5) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/05/2024.

  Patient problems: Visual Disturbances

  MAUDE report 19680530 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE REPORT #(B)(4) FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Disturbances

  MAUDE report 18887245 ↗