Light Adjustable Lens (LAL) 60007-0205Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00818806021590), received between Mar 27, 2024 and Sep 28, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 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 (OS) due to blurred vision and changes in manifest refraction (MR) secondary to suspected photopolymerization. The patient had completed two light treatments an no lock-in treatments before presenting to clinic one year later, complaining of blurry vision OS. Slit lamp examination revealed a small central bulge on the LAL+. Additionally, the patient reported not wearing RxSight UV protective eyewear while swimming. The LAL+ was explanted and replaced with another LAL+ without complications.

  Patient problems: Blurred Vision

  MAUDE report 50915980 ↗
• InjurySep 16, 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 after completion of light treatments due to dissatisfaction with near vision and a new Light Adjustable Lens implanted as a replacement.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50790250 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens+ (LAL+) was explanted due to blurry vision, difficulty judging distances and a change in refraction, diagnosed approximately 8 months after completion of light treatments. A new LAL+ was implanted as a replacement.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50212623 ↗
• InjuryJun 24, 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 PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET AND VISUAL QUALITY AFTER FINAL LOCK IN.

  Patient problems: Blurred Vision

  MAUDE report 25610595 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED AFTER 3 LIGHT ADJUSTMENTS DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25393852 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS+. THE LENS WAS IMPLANTED IN THE SULCUS AND A VITRECTOMY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 25262762 ↗
• InjuryApr 17, 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 THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Visual Impairment

  MAUDE report 24916746 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED DUE TO SUBJECTIVE VISUAL DISTURBANCES AND CLOUDY VISION DESPITE HAVING AN UNCORRECTED DISTANCE VISUAL ACUITY OF 20/20+1.

  Patient problems: Visual Disturbances

  MAUDE report 24904209 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  RXSIGHT RECEIVED A MEDWATCH REPORT MW5183895 DATED 03/12/2026. IN THIS MEDWATCH REPORT, A PATIENT STATED THAT SHE HAD THE LIGHT ADJUSTABLE LENS+ (LAL+) IMPLANTED IN HER RIGHT EYE WITH NO ISSUES POST-IMPLANTATION; HOWEVER, AFTER THE 1ST LIGHT ADJUSTMENT HER VISION BECAME WORSE. PER INFORMATION PROVIDED BY THE TREATING PHYSICIAN, THE PATIENT'S RIGHT EYE WAS BEING TARGETED FOR PLANO SPHERE. PRIOR TO THE 1ST LIGHT TREATMENT ON (B)(6) 2025, THE PATIENT'S UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 20/20, MANIFEST REFRACTION (MR) WAS -0.25 +0.25 X100 WITH BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) BEING 20/20. AFTER THE LIGHT TREATMENT ON (B)(6) 2025, THE PATIENT'S UCDVA WAS 20/25+2, MR WAS PLANO +0.75 X045 WITH BCDVA 20/20. PATIENT ALSO REPORTED BEING LIGHT SENSITIVE, HAVING STARBURSTS, SHADOWING, AND GHOSTING. FURTHERMORE, PATIENT REPORTED THAT THE TREATING PHYSICIAN NOTED OBSERVING CENTRAL CIRCLE/RING IN THE IOL. THE LAL+ WAS LATER EXPLANTED, AND THE PATIENT HAD A VITRECTOMY DUE TO PRIOR YAG CAPSULOTOMY. THE PATIENT ALLEGES, BASED ON INFORMATION OBTAINED ON SOCIAL MEDIA, THAT THE VISUAL DISTURBANCES THAT SHE EXPERIENCED WERE DUE TO NON-FOCUSED LIGHT ADJUSTMENTS; HOWEVER, THERE I

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24782106 ↗
• 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), +20.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND A NEW LAL+ (SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 23073856 ↗
• InjurySep 11, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.5D) WAS IMPLANTED (B)(6) 2024 IN THE RIGHT EYE. POSTOPERATIVELY THE PATIENT UNDERWENT 3 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. THE PATIENT RETURNED TO THE CLINIC (B)(6) 2025 COMPLAINING OF BLURRY DISTANCE VISION. THE TREATING PHYSICIAN NOTED AN AREA OF "SLIGHT DISTORTION" ON THE CENTER OF THE LENS CONSISTENT WITH POLYMERIZATION DUE TO NO LOCK-IN PERFORMED. ON (B)(6) 2025, APPROXIMATELY 18 MONTHS AFTER IMPLANT SURGERY, THE LAL+ WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23034152 ↗
• 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), +20.5D) WAS EXPLANTED FROM THEIR RIGHT EYE DUE TO DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22798613 ↗
• 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), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. PRIOR TO EXPLANT, THE TREATING PHYSICIAN NOTED THAT THE LENS WAS OBSERVED TO BE MILDLY DECENTERED TEMPORALLY. A NEW LAL (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22709422 ↗
• InjuryJul 25, 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), +20.5D) WAS INADVERTENTLY IMPLANTED IN THE RIGHT EYE (DOMINANT) INSTEAD OF THE LIGHT ADJUSTABLE LENS (LAL) AND SUBSEQUENTLY EXPLANTED DUE TO BLURRY VISION. A NEW LIGHT ADJUSTABLE LENS (SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22609521 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22510430 ↗
• InjuryMay 30, 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), +20.5D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND A NEW LAL+ (SN: (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22118068 ↗
• InjuryMay 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), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22099098 ↗
• 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 LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6),+20.5 D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET. A NEW LAL+ (SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22040726 ↗
• InjuryMar 31, 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), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND DISSATISFACTION WITH VISION.

  Patient problems: Visual Disturbances

  MAUDE report 21734852 ↗
• 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), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. A NEW LAL+ WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 21400909 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT THE LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. THE LENS WAS REPLACED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D).

  Patient problems: Visual Disturbances

  MAUDE report 21113877 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES THAT WERE PRESENT SINCE SURGERY. THE LAL+ WAS EXPLANTED AND REPLACED WITH A LAL.

  Patient problems: Visual Disturbances

  MAUDE report 21093222 ↗
• InjuryOct 11, 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), +20.5D) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE ON (B)(6) 2024, APPROXIMATELY 6 MONTHS AFTER COMPLETION OF LIGHT TREATMENTS, DUE TO PATIENT DISSATISFACTION WITH DISTANCE VISION. ANOTHER LAL+ (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 20434475 ↗
• InjurySep 6, 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), +20.5D) WAS EXPLANTED FROM THE RIGHT EYE AFTER TWO LIGHT TREATMENTS. THE PATIENT WAS DISSATISFIED WITH THE QUALITY OF THEIR VISION, SPECIFICALLY GLARE AND STARBURSTS. ANOTHER LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/08/2024. REFERENCE REPORT #3012712027-2024-00148 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 20163633 ↗
• InjuryAug 22, 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 HAD A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.5D) EXPLANTED FROM THE RIGHT EYE DUE TO POSSIBLE VISUAL CHANGES AFTER USE OF A TANNING BED WITHOUT RXSIGHT UV PROTECTIVE SPECTACLES PRIOR TO ANY LIGHT TREATMENTS BEING PERFORMED. EXAMINATION OF FRAGMENTS OF THE LENS RETURNED TO RXSIGHT AFTER EXPLANTATION DID NOT REVEAL OBVIOUS SIGNS OF ABNORMAL POLYMERIZATION. A NEW LAL (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/22/2024. REFERENCE REPORT #3012712027-2024-00078 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20033324 ↗