Light Adjustable Lens (LAL) 60007-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00818806021651), received between Sep 4, 2024 and Apr 29, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Optical Decentration” (1 report).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 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 DISTANCE VISION. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 25032609 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +23.5D) WAS EXPLANTED DUE TO MONOCULAR DIPLOPIA AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 24595973 ↗
• 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), +23.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION AND BLURRY VISION. THE LAL+ WAS EXPLANTED AND ANOTHER LAL+ (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24581825 ↗
• 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 IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +23.5D) WAS DIAGNOSED WITH ACUTE UVEITIS FOLLOWING THE FIRST LIGHT TREATMENT. THE PATIENT WAS TREATED AND RECEIVED TWO ADDITIONAL LIGHT ADJUSTMENTS FOLLOWING RESOLUTION DESPITE A MINIMAL REDUCTION IN BEST CORRECTED VISUAL ACUITY. THE LENS WAS EXPLANTED DUE TO BLURRY VISION AND THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 23705357 ↗
• InjuryNov 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+, SN (B)(6), +23.50) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND BOTH MONOCULAR AND BINOCULAR DIPLOPIA. THE TREATING PHYSICIAN NOTED THE BINOCULAR DIPLOPIA WAS CAUSED BY A DECOMPENSATED PHORIA.

  Patient problems: Diplopia/Double Vision

  MAUDE report 23658801 ↗
• 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), +23.5D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23068765 ↗
• 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), +23.5D) WAS EXPLANTED FROM THEIR RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23068739 ↗
• 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), +23.5D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO BLURRED VISION AND VISUAL DISTURBANCES. THE PATIENT'S SYMPTOMS CONTINUED FOLLOWING LENS REPLACEMENT WITH A NON-LAL IOL.

  Patient problems: Visual Disturbances

  MAUDE report 22891466 ↗
• InjuryAug 13, 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), +23.50D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22798614 ↗
• InjuryJul 28, 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), +23.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22630957 ↗
• InjuryJul 28, 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), +23.5D). THE LAL+ WAS PLACED IN THE SULCUS AND WAS OBSERVED TO BE DISPLACED SUPERIORLY AFTER THE SURGERY. NO FURTHER SURGICAL INTERVENTION WAS REQUIRED AND LIGHT TREATMENTS WERE SUCCESSFULLY PERFORMED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22630805 ↗
• InjuryMay 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23.5D) WAS EXPLANTED DUE TO AN INCORRECTLY CHOSEN IOL POWER DUE TO PTERYGIUM THAT INTERFERED WITH THE CALCULATION. A NEW LAL+ (SN (B)(6), +10.0D) WITH A DIFFERENT IOL POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21981499 ↗
• InjuryApr 21, 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), +23.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION IN VISION WITH THE CHOSEN REFRACTIVE TARGET. A NEW LAL (SN (B)(6), +23.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21877333 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23.5D) THE LEADING HAPTIC BROKE THE POSTERIOR CAPSULE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 21149624 ↗
• InjuryOct 24, 2024Use of Device Problem; Use of Device Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +23.5D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT UNDERWENT ONE LIGHT ADJUSTMENT AND DID NOT COMPLETE REMAINING LIGHT TREATMENTS. THE PATIENT SELF-REPORTED NOT FOLLOWING THE REQUIREMENTS FOR WEARING RXSIGHT UV SPECTACLES DURING THE POST-OPERATIVE PERIOD. THE LAL+ WAS EXPLANTED ON (B)(6) 2024, APPROXIMATELY 9 MONTHS AFTER THE IMPLANT SURGERY, DUE TO BLURRY VISION. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 20527978 ↗
• InjurySep 4, 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), +23.5D) WAS EXPLANTED ON (B)(6) 2024 DUE TO LENS DECENTRATION. NO LIGHT TREATMENTS WERE PERFORMED PRIOR TO EXPLANTATION. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 08/05/2024.

  Patient problems: Blurred Vision

  MAUDE report 20137552 ↗