RxSight Light Adjustable Lens (RxLAL) 60005-3130Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818806020579), received between Oct 19, 2021 and Sep 18, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Optical Problem

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 50826758 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, 13 DIOPTERS) WAS EXPLANTED AFTER THREE ADJUSTMENTS DUE TO A REFRACTIVE TARGET MISS AND A NEW LAL (14 DIOPTERS) WAS IMPLANTED AS A REPLACEMENT. THE SITE REPORTED THERE WAS NO PROBLEM WITH THE EXPLANTED LAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25681650 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED AFTER COMPLETION OF LIGHT TREATMENTS AND A NEW LAL IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25449317 ↗
• InjuryMay 14, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE APPROXIMATELY 10 MONTHS AFTER IMPLANTATION AND COMPLETION OF ALL LIGHT TREATMENTS DUE TO SUPERIOR DISPLACEMENT AND ANTERIOR TILT OF THE LAL, IN ADDITION TO PATIENT COMPLAINTS OF INTERMITTENT GLARE, BLURRINESS, INTERMITTENT IRRITATION AND PRESSURE WITH TIRING OF THE LEFT EYE. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Irritation; Visual Disturbances

  MAUDE report 25175052 ↗
• InjuryApr 17, 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 PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO THE PATIENT WANTING "MORE RANGE" IN THE RIGHT EYE AFTER THE FIRST LIGHT TREATMENT.

  Patient problems: Insufficient Information

  MAUDE report 24916760 ↗
• InjuryApr 6, 2026Prophylactic removal due to corrective action

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +13.0D) WAS IMPLANTED (B)(6) 2026. POSTOPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RETINAL DETACHMENT. THE RETINA SURGEON DETERMINED SILICONE OIL WAS NECESSARY TO TREAT THE PATIENT'S RETINAL DETACHMENT. THE LENS WAS EXPLANTED (B)(6) 2026.

  Patient problems: Retinal Detachment

  MAUDE report 24794810 ↗
• MalfunctionOct 16, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +13.0D) WAS IMPLANTED BACKWARDS IN THE EYE DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON DECIDED TO EXCHANGE THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464971 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +13.0D) WAS EXPLANTED ON (B)(6) 2024 FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH NEAR VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/29/2024. REFERENCE REPORT # 3012712027-2024-00111 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20082207 ↗
• InjuryJul 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +13.0D) WAS IMPLANTED ON (B)(6) 2023, WITH ANOTHER LAL IMPLANTED IN THE FELLOW EYE SEPARATELY. ON (B)(6) 2024, APPROXIMATELY 6 MONTHS AFTER THE IMPLANT SURGERY AND COMPLETION OF LIGHT TREATMENTS, THE LAL WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO MYOPIA THAT HAD BEEN TARGETED IN THE EYE BY THE TREATING PHYSICIAN. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/11/2024.

  Patient problems: Visual Impairment

  MAUDE report 19680891 ↗
• InjuryApr 9, 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 AND IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +13.0D), PERFORMED (B)(6) 2024, A CAPSULAR TEAR OCCURRED. ON (B)(6) 2024, A VITRECTOMY WAS PERFORMED, THE LAL WAS EXPLANTED AND A NEW LAL PLACED IN THE SULCUS AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 03/11/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19072718 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +13.0D) EXPLANTED FROM THE LEFT EYE (OS). THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL (SN (B)(6), +13.0D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023. REFERENCE MDR 3012712027-2023-00076 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17569283 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD HER LEFT EYE (OS) LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +13.0D) EXPLANTED DUE TO PATIENT DISSATISFACTION. THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/31/2023. REFERENCE MDR 3012712027-2023-00058 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Impairment

  MAUDE report 17195409 ↗
• InjuryJun 7, 2023Use of Device Problem; Use of Device Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +13.0D) WAS EXPLANTED DUE TO BEING IMPLANTED BACKWARD. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/12/2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17083921 ↗
• InjuryOct 19, 2021Unintended Movement; Unintended Movement

  THE SITE REPORTED DURING DELIVERY OF THE LAL, THE LENS EXITED THE CARTRIDGE ABRUPTLY, CAUSING THE HAPTIC TO TEAR THE POSTERIOR CAPSULAR BAG. THE PHYSICIAN COMPLETED A VITRECTOMY, REMOVED THE LAL, AND IMPLANTED A LI60 IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS ISSUE WAS (B)(6) 2021.

  Patient problems: Capsular Bag Tear

  MAUDE report 12656928 ↗