RxSight Light Adjustable Lens (RxLAL) 60005-3260Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818806020777), received between Nov 1, 2023 and Jul 1, 2026 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Use of Device Problem; Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL). POSTOPERATIVELY, THE PATIENT COMPLETED 4 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. THE PATIENT PRESENTED AT THE CLINIC APPROXIMATELY 13 MONTHS AFTER INITIAL IMPLANTATION WITH A VISUAL ACUITY OF 20/30 AND HIGH ASTIGMATIC ERROR WITH DISTORTION ON RETINOSCOPY EXAM. THE SITE REPORTED THAT THE PATIENT WAS EXPOSED TO ARC LIGHT WHEN WELDING AND A SLIT LAMP EXAM PERFORMED BY THE SITE FOUND AN AREA OF DISTORTION THAT IS CONSISTENT WITH POLYMERIZATION. APPROXIMATELY 13 MONTHS AFTER IMPLANTATION, THE LAL WAS EXPLANTED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25681653 ↗
• InjuryDec 10, 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), +26.0D). A VITRECTOMY WAS PERFORMED, AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23771506 ↗
• InjuryOct 21, 2025Device Handling Problem; Device Handling Problem

  A SITE REPORTED TO RXSIGHT THAT DURING THE INITIAL IMPLANTATION SURGERY OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +26.0D), ON (B)(6) 2025, THE SURGEON BELIEVES THAT THE OPTIC BODY WAS DAMAGED DURING LOADING DUE TO SCRATCHES OBSERVED ON THE LENS DURING A POSTOPERATIVE EXAM, PRIOR TO LIGHT TREATMENTS. THE LAL WAS EXPLANTED ON (B)(6) 2025 AND REPLACED WITH ANOTHER LAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351055 ↗
• InjuryAug 27, 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), +26.0D) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR.

  Patient problems: Blurred Vision

  MAUDE report 22903332 ↗
• InjuryAug 25, 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), SERIAL NUMBER (B)(6), +26.0D, WAS EXPLANTED FROM THEIR LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22891113 ↗
• InjuryJun 3, 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), +26.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22137775 ↗
• InjuryDec 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), +26.0D), A POSTERIOR CAPSULE TEAR AND DEHISCENCE OF A PREVIOUS RADIAL KERATOTOMY INCISION OCCURRED. THE RK INCISION WAS SUTURED, A VITRECTOMY WAS PERFORMED, AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear; Wound Dehiscence

  MAUDE report 20886133 ↗
• InjuryJun 3, 2024Use of Device Problem; Use of Device Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +26.0D) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT COMPLETED ONE LIGHT ADJUSTMENT TREATMENT DURING THE POSTOPERATIVE PERIOD. THE PATIENT DID NOT COMPLETE THE REQUIRED LOCK-IN LIGHT TREATMENTS. ON (B)(6) 2024, APPROXIMATELY 10 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/08/2024. REFERENCE REPORT #3012712027-2024-00092 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Blurred Vision

  MAUDE report 19454576 ↗
• InjuryJun 3, 2024Use of Device Problem; Use of Device Problem

  A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +26.0D) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT COMPLETED TWO LIGHT ADJUSTMENT TREATMENTS DURING THE POSTOPERATIVE PERIOD. THE PATIENT DID NOT COMPLETE THE REQUIRED LOCK-IN LIGHT TREATMENTS. ON (B)(6) 2024, APPROXIMATELY 10 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/08/2024. REFERENCE REPORT # (B)(4) FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19454496 ↗
• InjuryNov 1, 2023Adverse 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), +26.0D) WAS EXPLANTED DUE TO A RESIDUAL REFRACTIVE ERROR AFTER LIGHT TREATMENTS. THE LAL WAS REPLACED WITH ANOTHER NON-LAL LENS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18051730 ↗