Light Adjustable Lens (LAL) 60007-0200Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00818806021583), received between Mar 27, 2024 and Jun 2, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

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 25 most recent of 31 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 RIGHT 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 25362278 ↗
• InjuryApr 16, 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+). AN ANTERIOR VITRECTOMY WAS PERFORMED, AND THE LAL+ WAS PLACED IN THE SULCUS WITH OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24899178 ↗
• InjuryApr 6, 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), +20.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO A CENTRAL RING OF HAZE ON THE LENS THAT RESULTED IN BLURRY VISION. A NEW LAL (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24790379 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +20.0D) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24771517 ↗
• 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), +20.0D) WAS IMPLANTED ON (B)(6) 2025 IN THE LEFT EYE. PRIOR TO BEGINNING LIGHT TREATMENTS, THE PATIENT REQUESTED EXPLANTATION OF THE LENS AND NO LIGHT TREATMENTS WERE COMPLETED DURING THE POSTOPERATIVE PERIOD. THE LAL+ WAS EXPLANTED ON (B)(6) 2026 DUE TO THE PATIENT'S DISSATISFACTION WITH VISION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24594321 ↗
• InjuryMar 4, 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), +20.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24506894 ↗
• 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), +20.0D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24087850 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERAL PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) IN THE RIGHT EYE ON (B)(6) 2024. POSTOPERATIVELY, THE PATIENT'S LIGHT TREATMENT WAS DELAYED DUE TO MACULAR HEME AND UNDERGOING ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) INJECTIONS. THE PATIENT UNDERWENT 2 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. THE PATIENT COMPLAINED OF BLURRY VISION WITH GHOST IMAGE. ON (B)(6) 2025, APPROXIMATELY 11 MONTHS AFTER IMPLANTATION, THE LAL+ WAS EXPLANTED DUE TO BLURRED VISION AND VISUAL DISTURBANCE. AFTER EXPLANTATION AND LENS EXCHANGE WITH A MONOFOCAL IOL, THE PATIENT'S SYMPTOMS PERSISTED WITH GHOSTING IMAGE AT 4 TO 5 FEET. THE TREATING PHYSICIAN INDICATED THAT GHOSTING IS DUE TO THE PATIENT'S CORNEAL ASTIGMATISM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23873597 ↗
• InjuryDec 17, 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), +20.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCE AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Disturbances

  MAUDE report 23830027 ↗
• InjuryDec 17, 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), +20.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCE AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 23829737 ↗
• InjuryNov 25, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +20.0D) IN THE RIGHT EYE ON (B)(6) 2024. THE PATIENT COMPLETED ONE LIGHT ADJUSTMENT ON (B)(6) 2024 AND WAS LOST TO FOLLOW UP. THE PATIENT RETURNED TO CLINIC APPROXIMATELY 16 MONTHS LATER WITH COMPLAINTS OF HALOS. ON (B)(6) 2025, THE TREATING PHYSICIAN OBSERVED CENTRAL IOL IRREGULARITIES CONSISTENT WITH PREMATURE PHOTOPOLYMERIZATION DUE TO UV SPECTACLE NONCOMPLIANCE. THE LAL+ WAS EXPLANTED ON (B)(6) 2025 AND A NEW LAL+ (SN: (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Halo

  MAUDE report 23649831 ↗
• InjuryNov 25, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) IN THE LEFT EYE ON (B)(6) 2024. THE PATIENT COMPLETED ONE LIGHT ADJUSTMENT ON (B)(6) 2024 AND WAS LOST TO FOLLOW UP. THE PATIENT RETURNED TO CLINIC APPROXIMATELY 16 MONTHS LATER WITH COMPLAINTS OF HALOS. ON (B)(6) 2025, THE TREATING PHYSICIAN OBSERVED CENTRAL IOL IRREGULARITIES CONSISTENT WITH PREMATURE PHOTOPOLYMERIZATION DUE TO UV SPECTACLE NONCOMPLIANCE. THE LAL+ WAS EXPLANTED ON (B)(6) 2025 AND A NEW LAL+ (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Halo

  MAUDE report 23649827 ↗
• InjurySep 17, 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), +20.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +19.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 23073860 ↗
• InjuryAug 25, 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), +20.0D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO BLURRY VISION. A NEW LAL+ (SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22891331 ↗
• InjuryAug 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), +20.0D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET. AN LAL (SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22840850 ↗
• InjuryAug 5, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) WAS IMPLANTED ON (B)(6) 2025. AFTER 3 LIGHT TREATMENTS, THE TREATING PHYSICIAN OBSERVED THAT THE LENS WAS DISLOCATED. THE LAL+ WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 22717424 ↗
• 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 LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND BLURRED VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22716633 ↗
• InjuryJul 22, 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), +20.0D) WAS EXPLANTED DUE TO MONOCULAR DIPLOPIA AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +19.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 22567014 ↗
• InjuryJul 15, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0) WAS IMPLANTED ON (B)(6) 2025. AFTER 2 LIGHT TREATMENTS, THE TREATING PHYSICIAN OBSERVED THAT THE LENS WAS DISLOCATED. THE LAL+ WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 22510467 ↗
• InjuryJul 15, 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), +20.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCE. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22509979 ↗
• 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), 20.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 22040069 ↗
• InjuryMay 9, 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+(B)(6)) WAS EXPLANTED FROM THE RIGHT EYE DUE TO UNHAPPINESS WITH UNCORRECTED INTERMEDIATE AND NEAR VISION AND A NEW LAL (SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21998038 ↗
• InjuryMay 7, 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), +20.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH FINAL VISUAL OUTCOME. A LAL (SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21981370 ↗
• InjuryApr 29, 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)(4)., +20.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. A NEW LAL (SN (B)(4)., +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 21930528 ↗
• InjuryApr 18, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) WAS IMPLANTED ON (B)(6) 2024. ONE LIGHT TREATMENT WAS PERFORMED BUT NO LOCK INS WERE COMPLETED. THE LENS WAS EXPLANTED APPROXIMATELY 10 MONTHS AFTER IMPLANTATION DUE TO BLURRY VISION AND VISUAL DISTURBANCES. THE TREATING DOCTOR NOTED THAT THE PATIENT REPORTED USING A TANNING BED WITHOUT THE LAL+ BEING LOCKED IN.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21868553 ↗