RxSight Light Adjustable Lens (RxLAL) 60005-3225Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00818806020722), received between Jul 18, 2022 and Jun 25, 2026 — classified as 27 injuries, 1 malfunction.

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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT EXPERIENCED NO REFRACTIVE CHANGES AFTER A LIGHT ADJUSTMENT. UPON EXAMINATION, THE LENS WAS NOTED TO BE IMPLANTED BACKWARDS. FURTHER LIGHT TREATMENTS HAVE BEEN POSTPONED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25623329 ↗
• InjuryMay 28, 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 IN THE LEFT EYE. THE LENS WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. THE SURGEON DID NOT REPORT ANY ISSUES WITH THE LENS OR CONCOMITANT INJECTOR. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 25325834 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH THE VISUAL OUTCOME AFTER 3 LIGHT ADJUSTMENTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25306166 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.50D) WAS EXPLANTED PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND A NEW LAL WITH A SIGNIFICANT DIOPTER DIFFERENCE (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24747874 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCE. ANOTHER LAL (SN (B)(6), +23.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24721982 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +22.5D). A VITRECTOMY WAS PERFORMED AND THE LAL WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24623768 ↗
• 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), +22.5D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL (SN (B)(6), +22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24597764 ↗
• InjuryFeb 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), +22.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24378536 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) IN THE SULCUS AND UNDERWENT CONCURRENT DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY (DMEK) ON (B)(6) 2025. THE PATIENT WAITED SEVERAL MONTHS BEFORE STARTING LIGHT TREATMENTS. UPON RETURN TO CLINIC ON (B)(6) 2025, THE LENS WAS NOTED TO BE PARTIALLY DISLOCATED FROM THE SULCUS. A SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REPOSITION THE LENS. ON (B)(6) 2025, THE PATIENT REPORTED BLURRY VISION AND SHADOWING PRIOR TO COMPLETING THEIR FIRST LIGHT ADJUSTMENT. DURING THE NEXT VISIT ON (B)(6) 2025, APPROXIMATELY 7 MONTHS AFTER IMPLANTATION, THE TREATING PHYSICIAN NOTED POSSIBLE POLYMERIZATION OF THE LENS. DESPITE PATIENT COMPLAINTS OF BLURRY VISION, FINAL LOCK-IN WAS COMPLETED ON (B)(6) 2025. ON (B)(6) 2026, THE LAL WAS EXPLANTED DUE TO VISUAL DISTURBANCES SECONDARY TO IOL CHANGES CONSISTENT WITH POLYMERIZATION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24270011 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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, SN (B)(6), +22.5D).

  Patient problems: Capsular Bag Tear

  MAUDE report 23609012 ↗
• InjuryNov 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), +22.50D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 23548901 ↗
• 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), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCES AND BLURRED VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23381142 ↗
• 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) +22.5D) WAS EXPLANTED DUE TO BLURRY DISTANCE VISION AND A NEW LAL SN (B)(6)+22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23357626 ↗
• InjurySep 2, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A SURGEON REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS IMPLANTED BACKWARDS. A SMALL CAPSULE TEAR OCCURRED WHILE THE SURGEON WAS FLIPPING THE LAL TO THE CORRECT ORIENTATION. AFTER FLIPPING THE LAL, THE SURGEON PLACED THE LAL INTO THE SULCUS AND CLOSED THE INCISION WITH SUTURES.

  Patient problems: Capsular Bag Tear

  MAUDE report 22939110 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21980589 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS EXPLANTED DUE TO BLURRY DISTANCE VISION AND A NEW LAL (SN (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21574209 ↗
• 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 LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +22.5D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH FINAL VISUAL OUTCOME.

  Patient problems: Visual Impairment

  MAUDE report 21304704 ↗
• InjuryJan 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)) WAS IMPLANTED ON (B)(6) 2023. APPROXIMATELY 3 MONTHS AFTER SURGERY, THE PATIENT REPORTED SUDDEN ONSET OF BLURRY DISTANCE VISION AND VISUAL DISTURBANCES AFTER FAILURE TO WEAR THEIR RXSIGHT UV PROTECTIVE EYEWEAR FOR 1 WEEK DUE TO LOSS OF THE GLASSES. THE CLINICAL EVALUATION FOUND AN AREA ON THE LENS THAT IS SUSPICIOUS OF UNINTENDED REFRACTIVE CHANGES. THE LAL WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21180825 ↗
• InjuryNov 6, 2024Use of Device Problem; Use of Device Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2023. THE PATIENT UNDERWENT 4 LIGHT ADJUSTMENTS ON THE EYE AND NO LOCK-IN PROCEDURES. THE LAL WAS EXPLANTED ON (B)(6) 2024, APPROXIMATELY 16 MONTHS AFTER THE IMPLANT SURGERY, DUE TO SUBJECTIVE VISUAL DISTURBANCE. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. REFERENCE REPORT #3012712027-2024-00193 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 20625246 ↗
• InjuryNov 1, 2024Use of Device Problem; Use of Device Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT UNDERWENT 4 LIGHT ADJUSTMENTS ON THE EYE AND NO LOCK-IN PROCEDURES. THE LAL WAS EXPLANTED ON (B)(6) 2024, APPROXIMATELY 16 MONTHS AFTER THE IMPLANT SURGERY, DUE TO SUBJECTIVE VISUAL DISTURBANCE. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. REFERENCE REPORT #3012712027-2024-00194 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 20592426 ↗
• InjuryOct 17, 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'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND A NEW LAL (SN (B)(6), +22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 20477639 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH HISTORY OF BILATERAL RADIAL KERATOTOMY AND CORNEAL EDEMA UNDERWENT EXPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) IN THEIR RIGHT EYE. THE LAL WAS IMPLANTED ON (B)(6) 2024. THE PATIENT COMPLAINED OF VISUAL DISTURBANCE PRIOR TO THE FIRST LIGHT ADJUSTMENT ON (B)(6) 2024, WHICH PERSISTED UP TO THE EXPLANT DATE. A NEW LAL (SN (B)(6), +22.5D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/26/2024. REFERENCE REPORT #3012712027-2024-00165 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 20273921 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT UPON INSERTION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.5D) DURING PRIMARY CATARACT SURGERY, A POSTERIOR CAPSULE TEAR OCCURRED. THE LAL WAS LIFTED INTO THE ANTERIOR CHAMBER AND THE HAPTICS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/26/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 20057186 ↗
• InjuryMar 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), +22.5D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS COMPLETED TO EXPLANT THE LAL AND IMPLANT A NEW LAL (SN: (B)(6), +22.5D) IN THE CORRECT ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/06/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18852350 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6) +22.5D) WAS EXPLANTED ON (B)(6)2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17322306 ↗