RxSight Light Adjustable Lens (RxLAL) 60005-3250Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00818806020760), received between Aug 11, 2022 and Aug 10, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Optical Decentration” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Optical Problem

  A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens (LAL) was explanted from the left eye due to poor quality of vision despite a best-corrected distance vision of 20/20. Additionally, the physician described the lens appearance as "hazy". A new LAL was implanted as a replacement. No additional information has been provided.

  Patient problems: Blurred Vision

  MAUDE report 50193888 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO REFRACTIVE SURPRISE. NO LIGHT TREATMENTS WERE PERFORMED PRIOR TO EXPLANT.

  Patient problems: Blurred Vision

  MAUDE report 24778073 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) WAS EXPLANTED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24641553 ↗
• InjuryMar 17, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6), +25.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2025. NO LIGHT TREATMENTS WERE PERFORMED BEFORE THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2026 COMPLAINING OF BLURRY VISION. EXAMINATION REVEALED CENTRAL IOL DISTORTION AFTER REPORTED TANNING BED USE. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND A NEW LAL (SN (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24623762 ↗
• InjuryMar 6, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +25.0D) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2024. DURING THE POSTOPERATIVE PERIOD, PATIENT HAD 1 LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS. THE PATIENT WAS LOST TO FOLLOW UP AND UPON RETURNING TO THE CLINIC ON (B)(6) 2026, THE PATIENT COMPLAINED OF HAVING A CONSTANT HALO IN THEIR VISION. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026.

  Patient problems: Halo

  MAUDE report 24538156 ↗
• InjuryDec 31, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) ON (B)(6) 2025. ON POSTOPERATIVE EXAM, THE LAL WAS NOTED TO BE SUBLUXATED, WITH ONE OF THE HAPTICS DISPLACED SUPERIORLY OVER THE IRIS. ON (B)(6) 2025, A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE LENS AND HAPTIC.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23936881 ↗
• InjuryJul 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) ON (B)(6) 2024. THE PATIENT DID NOT COMPLETE REQUIRED LOCK-IN LIGHT TREATMENTS. APPROXIMATELY 12 MONTHS AFTER IMPLANTATION, THE PATIENT PRESENTED COMPLAINING OF BLURRY DISTANCE VISION IN BOTH EYES AND REPORTED THAT THEY USED A TANNING BED 20 TIMES. THE LAL WAS EXPLANTED FROM THE RIGHT EYE ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 22460910 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO DISSATISFACTION WITH VISION PRIOR TO LIGHT TREATMENT COMPLETION.

  Patient problems: Blurred Vision

  MAUDE report 22101370 ↗
• 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 LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21981428 ↗
• InjuryApr 29, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS IMPLANTED ON (B)(6) 2024. DURING FOLLOW UP EXAMINATION ON (B)(6) 2024, THE LENS APPEARED TO BE TILTED. A SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO REPOSITION THE LENS AND PERFORM A VITRECTOMY.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21930295 ↗
• InjuryApr 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +25.0D) ON (B)(6) 2024. THE PATIENT DID NOT COMPLETE REQUIRED LOCK-IN LIGHT TREATMENTS. APPROXIMATELY 12 MONTHS AFTER IMPLANTATION, THE PATIENT PRESENTED COMPLAINING OF BLURRY DISTANCE VISION IN BOTH EYES AND REPORTED THAT THEY USED A TANNING BED 20 TIMES. THE LAL WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision

  MAUDE report 21891128 ↗
• 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), +25.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE AMOUNT OF MYOPIA THAT WAS TARGETED IN THIS EYE BY THE TREATING PHYSICIAN; A NEW LAL (SN (B)(6), +25.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/23/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20021255 ↗
• InjuryMar 21, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS LAL, SN (B)(6) WAS EXPLANTED AND A NEW LAL SN (B)(6) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/20/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18954187 ↗
• InjuryJul 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN: (B)(6), +25.0D) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE AFTER IMPLANT PRIOR TO ANY LIGHT TREATMENTS. THE LAL WAS EXPLANTED AND REPLACED WITH ANOTHER LAL. RXSIGHT'S DATE OF FIRST AWARENESS WAS 06/19/2023.

  Patient problems: Visual Impairment

  MAUDE report 17356069 ↗
• InjuryJul 14, 2023Optical Decentration; Optical Decentration

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS EXPLANTED DUE TO NOT BEING CENTERED WELL IN THE BAG. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/16/2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17330291 ↗
• InjuryAug 11, 2022Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 7/11/2022. THE LENS IS IN PROCESS OF BEING EVALUATED.

  Patient problems: Visual Impairment

  MAUDE report 15214124 ↗