RxSight Light Adjustable Lens (RxLAL) 60005-3230Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00818806020739), received between Aug 15, 2022 and Jul 31, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that patient's Light Adjustable Lens (LAL) was explanted from the right eye due to blurry vision and visual disturbances. No additional information has been provided.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50105318 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED ON (B)(6) 2023 IN THE RIGHT EYE. POSTOPERATIVELY, THE PATIENT COMPLETED ALL LIGHT TREATMENTS; THE RIGHT EYE WAS TARGETED FOR NEAR VISION AND THE LEFT EYE FOR DISTANCE. ON (B)(6) 2026, THE PATIENT'S LAL WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET, VISUAL DISTURBANCES AND MONOCULAR DIPLOPIA. POSTOPERATIVELY, THE PATIENT WAS REPORTED TO BE SATISFIED WITH THEIR VISION AND NO LONGER WAS EXPERIENCING VISUAL DISTURBANCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 24944978 ↗
• InjuryMar 31, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +23.0D) IN THE LEFT EYE. THE PATIENT COMPLETED 5 LIGHT ADJUSTMENTS POST-OPERATIVELY BUT DID NOT COMPLETE THE REQUIRED LOCK IN TREATMENTS. ON (B)(6) 2026, APPROXIMATELY 26 MONTHS LATER, THE PATIENT RETURNED TO CLINIC COMPLAINING OF BLURRY VISION AND VISUAL DISTURBANCES. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24743631 ↗
• MalfunctionFeb 27, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +23.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE LAL WAS REMOVED AND ANOTHER LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466119 ↗
• InjuryFeb 18, 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 (LAL, SN (B)(6), +23.0D). THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24379257 ↗
• InjuryNov 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), +23.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23623904 ↗
• InjuryNov 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), +23.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH VISUAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500412 ↗
• InjuryNov 6, 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), +23.0D). THE LAL HAPTICS WERE PLACED IN THE SULCUS WITH OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23490416 ↗
• 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), +23.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES AND BLURRED VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23381144 ↗
• 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), +23.0D) WAS EXPLANTED DUE TO BLURRED VISION.

  Patient problems: Blurred Vision

  MAUDE report 23381141 ↗
• InjuryAug 19, 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)+23.0D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +23.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22840957 ↗
• InjuryJul 7, 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), +23.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND PATIENT DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22420234 ↗
• 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), +23.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND BLURRED VISION AND A NEW LAL (B)(6), +23.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22342612 ↗
• InjuryMay 21, 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), +23.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Insufficient Information

  MAUDE report 22063326 ↗
• InjuryJan 21, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY, ON (B)(6) 2024, AFTER DELIVERY OF THE LIGHT ADJUSTABLE LENS (LAL, (B)(6), +23D) IN THE PATIENT'S EYE, IT WAS OBSERVED THAT A HAPTIC HAD DISINSERTED. AN ADDITIONAL PROCEDURE WAS COMPLETED ON 12/26/2024 TO EXPLANT THE LAL AND IMPLANT A NEW LAL ((B)(6), +24D) AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21198769 ↗
• 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 A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +23.0D) IN THEIR LEFT 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 08/23/2024. REFERENCE REPORT #3012712027-2024-00166 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 20274070 ↗
• InjuryAug 21, 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), +23.0D) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERRORS; A NEW LAL (SN (B)(6), +23.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/24/2024.

  Patient problems: Visual Impairment

  MAUDE report 20020474 ↗
• InjuryJun 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AND A NEW LAL (SN (B)(6) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Visual Impairment

  MAUDE report 19610861 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING PRIMARY CATARACT SURGERY, A CAPSULAR BAG TEAR WAS NOTED. AN ATTEMPT WAS MADE TO IMPLANT 2 LIGHT ADJUSTABLE LENSES (LAL, SERIAL NUMBERS (B)(6)), HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. A VITRECTOMY WAS PERFORMED AND A 3RD LAL WAS IMPLANTED SUCCESSFULLY. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/15/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19102126 ↗
• InjuryMar 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) 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)) IN THE CORRECT ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19005875 ↗
• InjuryAug 15, 2022Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME DUE TO UNRESOLVED RESIDUAL ASTIGMATISM AFTER 3 ADJUSTMENTS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15230254 ↗