Light Adjustable Lens (LAL) 60007-0195Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00818806021576), received between Sep 6, 2024 and May 22, 2026 — classified as 29 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 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 DESPITE HAVING GOOD VISION POST-IMPLANTATION. THE TREATING PHYSICIAN STATED THAT THE PATIENT WANTED A MULTIFOCAL IOL DUE TO THE POSSIBILITY OF OBTAINING GREATER RANGE OF VISION. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25257251 ↗
• InjuryMay 14, 2026Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED FROM THE LEFT EYE DUE TO DIPLOPIA. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Diplopia/Double Vision

  MAUDE report 25174016 ↗
• 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), +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND A PRESSURE SENSATION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Eye Pain; Visual Disturbances

  MAUDE report 24794812 ↗
• InjuryMar 31, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5D) WAS IMPLANTED (B)(6) 2024. AFTER THREE ADJUSTMENT LIGHT TREATMENTS, THE PATIENT COMPLAINED OF BLURRY VISION AND REPORTED DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET. AT A FOLLOW UP VISIT, THE LENS WAS OBSERVED TO BE SLIGHTLY DISPLACED. THE PATIENT THEN UNDERWENT A PRK PROCEDURE AND A FOURTH ADJUSTMENT BEFORE THE LENS WAS EXPLANTED. A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24747875 ↗
• 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), +19.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO MONOCULAR DIPLOPIA AND VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 23829819 ↗
• InjuryOct 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), +19.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION. A NEW LAL (SN (B)(6), +19.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23406156 ↗
• InjuryOct 24, 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), +19.50D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND BLURRY VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23386492 ↗
• InjuryOct 24, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.50D) WAS IMPLANTED IN THE RIGHT EYE IN 2024. POSTOPERATIVELY, THE PATIENT UNDERWENT 2 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. THE SITE REPORTED AN AREA ON THE LENS CONSISTENT WITH POLYMERIZATION AND THE LAL+ WAS EXPLANTED (B)(6) 2025.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23386491 ↗
• InjuryOct 23, 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), +19.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Impairment

  MAUDE report 23375252 ↗
• InjuryOct 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), +19.5D) WAS EXPLANTED FROM THE LEFT EYE AFTER ONE ADJUSTMENT LIGHT TREATMENT DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 23358881 ↗
• InjuryAug 27, 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), +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET AND VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 22903331 ↗
• InjuryAug 7, 2025Use of Device Problem; Use of Device Problem

  A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2024. THE PATIENT DID NOT RETURN TO THE CLINIC FOR 9 MONTHS AFTER ON (B)(6) 2024. AT THE TIME, THE PATIENT HAD ONLY ONE LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS. UPON RETURNING TO CLINIC ON (B)(6) 2025, THE PATIENT COMPLAINED OF AN ABRUPT CHANGE IN VISION AND HALOS. ON (B)(6) 2025, APPROXIMATELY 12 MONTHS AFTER THE IMPLANT SURGERY, THE LAL+ WAS EXPLANTED. A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22741983 ↗
• InjuryJul 15, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5D) WAS EXPLANTED DUE TO BLURRY VISION AND LENS DISLOCATION.

  Patient problems: Blurred Vision

  MAUDE report 22509978 ↗
• 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), +19.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCE. A NEW LAL (SN (B)(6), +19.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22509977 ↗
• InjuryJun 20, 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), +19.5D) WAS EXPLANTED DUE TO BLURRED VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +19.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22302973 ↗
• InjuryMay 30, 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), +19.5D) AND THE LAL+ WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22119338 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT, DUE TO A PATIENT'S DISSATISFACTION WITH VISION THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5D) WAS EXPLANTED FROM THE LEFT EYE AND A REPLACEMENT LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.5D) WAS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 22063422 ↗
• 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), +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO UNHAPPINESS WITH UNCORRECTED INTERMEDIATE AND NEAR VISION AND A NEW LAL (B)(6), +20.0D IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21998043 ↗
• InjuryApr 22, 2025Adverse 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), +19.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES AND A NEW LAL (SN (B)(6), +19.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21884623 ↗
• InjuryMar 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 WITH A HISTORY OF LASIK, LARGE PUPILS, AND DRY EYE HAD THEIR LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5D) EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21688202 ↗
• InjuryMar 18, 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), +19.5D) WAS EXPLANTED DUE TO DIPLOPIA AND VISUAL DISTURBANCES. A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO HAVE CONTINUED TO EXPERIENCE DIPLOPIA 1-DAY POST EXPLANT.

  Patient problems: Diplopia/Double Vision; Visual Impairment

  MAUDE report 21632884 ↗
• InjuryMar 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) +19.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCE. A NEW LAL+ (B)(6), +20D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21600553 ↗
• InjuryMar 11, 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), +19.5D) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Visual Impairment

  MAUDE report 21575601 ↗
• InjuryFeb 18, 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), +19.5D) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO VISUAL DISTURBANCES. A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21402811 ↗
• InjuryFeb 4, 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), +19.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND A NEW LAL (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21305197 ↗