Light Adjustable Lens (LAL) 60007-0190Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00818806021569), received between Jul 24, 2024 and Jun 24, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Optical Decentration” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Use of Device Problem; Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED FROM THE LEFT EYE DUE TO REPORTED CHANGES IN VISION. THE PATIENT DID NOT COMPLETE THE PRESCRIBED POSTOPERATIVE LIGHT TREATMENT REGIMEN AND WAS INCONSISTENT WITH USE OF RECOMMENDED UV-PROTECTIVE EYEWEAR. A REPLACEMENT LAL WAS SUBSEQUENTLY IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25610593 ↗
• InjuryApr 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 BLURRY DISTANCE VISION AND A NEW LAL+ IMPLANTED AS A REPLACEMENT. THE PATIENT'S BLURRY DISTANCE VISION WAS REPORTED TO BE IMPROVING POSTOPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 24916742 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE, REPORTED TO RXSIGHT, THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.0D) WAS IMPLANTED (B)(6) 2025 IN THE RIGHT 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 24626404 ↗
• 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), +19.0D) WAS EXPLANTED DUE TO BLURRY VISION. A NEW LAL+ (SN (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22716635 ↗
• InjuryAug 4, 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), +19.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22709423 ↗
• InjuryJul 24, 2025Optical Decentration; Optical Decentration

  A SURGEON REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), 19.0D) HAD PROLAPSED AFTER THE IMPLANT SURGERY AND A SECONDARY SURGERY WAS PERFORMED ON (B)(6) 2025 TO REPOSITION THE LENS BACK INTO THE CAPSULE. IT WAS DISCOVERED LATER THAT THE LENS WAS IMPLANTED BACKWARDS IN THE EYE AFTER LIGHT ADJUSTMENTS WERE PERFORMED. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE AND NO ADDITIONAL SURGICAL INTERVENTION WAS COMPLETED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22592635 ↗
• InjuryJul 17, 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), +19.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET AND DIPLOPIA.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 22532857 ↗
• InjuryJun 26, 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), +19.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, (B)(6), +21.0) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22342658 ↗
• 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 LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.0D) WAS EXPLANTED PRIOR TO LIGHT TREATMENTS DUE TO BLURRY VISION AND REDUCED VISUAL POTENTIAL. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. PATIENT WAS SUBSEQUENTLY REFERRED FOR EVALUATION OF SUSPECTED OPTIC NEUROPATHY.

  Patient problems: Blurred Vision

  MAUDE report 22203351 ↗
• InjuryMar 31, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device 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), +19.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21734860 ↗
• InjuryMar 31, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.0D) ON (B)(6) 2025. ON (B)(6) 2025, AN ADDITIONAL PROCEDURE WAS PERFORMED AND THE LAL+ WAS PLACED IN THE SULCUS. ON (B)(6) 2025, A PROCEDURE WAS PERFORMED TO REPOSITION THE LAL+; THE HAPTICS WERE PLACED IN THE SULCUS AND THE LENS WAS PLACED IN THE CAPSULAR BAG.

  Patient problems: Capsular Bag Tear

  MAUDE report 21734851 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE THE SURGEON WAS IMPLANTING THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.0D) A POSTERIOR CAPSULE TEAR OCCURRED. A VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 21625631 ↗
• InjuryNov 12, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN(B)(6), +19.0D) WAS IMPLANTED (B)(6)2024. DURING THE POSTOPERATIVE PERIOD, THE PATIENT COMPLAINED OF BLURRY VISION AND THE TREATING PHYSICIAN OBSERVED THAT THE OPTIC WAS PROLAPSED INFERIORLY. THE PHYSICIAN CHOSE TO EXPLANT THE LAL+ ON (B)(6)2024 AND REPLACE WITH AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER.

  Patient problems: Blurred Vision

  MAUDE report 20667442 ↗
• 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), +19.0D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 20529436 ↗
• InjuryJul 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.0D) WAS EXPLANTED DUE TO BLURRY VISION AFTER COMPLETION OF 1 LIGHT TREATMENT. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/26/2024.

  Patient problems: Visual Impairment

  MAUDE report 19823287 ↗