RxSight Light Adjustable Lens (RxLAL) 60005-3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00818806020678), received between Jan 18, 2022 and Aug 13, 2026 — classified as 47 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A site reported a capsular tear during implantation of a Light Adjustable Lens (LAL). The lens was successfully implanted in the sulcus. No additional information has been provided.

  Patient problems: Capsular Bag Tear

  MAUDE report 50235564 ↗
• InjuryAug 7, 2026Optical Problem

  Patient problems: Visual Disturbances

  MAUDE report 50177585 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens (LAL) was explanted from the right eye due to binocular and monocular diplopia after completion of light treatments. Following cataract surgery and the onset of symptoms, the patient was diagnosed with alternating exotropia (no improvement with prism) and described as a monofixator after reporting feeling as though their eyes were "crossing" while driving.

  Patient problems: Diplopia/Double Vision

  MAUDE report 50159649 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a patient's Light Adjustable Lens (LAL, +20.0D) was explanted due to a refractive surprise after implantation. A new LAL of a different power (22.5D) was implanted as a replacement. The patient is reported to be doing well post-operatively. No additional information has been provided.

  Patient problems: Blurred Vision

  MAUDE report 50015882 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  RXSIGHT RECEIVED A REPORT OF A BILATERALLY IMPLANTED PATIENT WHO RETURNED TO THE CLINIC AFTER THE INITIAL LIGHT ADJUSTMENT COMPLAINING OF BLURRY VISION. UPON EXAMINATION, THE PATIENT WAS NOTED TO HAVE CHEMOSIS, AND WAS TREATED WITH A STEROID. HOWEVER, THE PATIENT DID NOT WANT TO WAIT FOR THEIR VISION TO STABILIZE AND EYE IMPROVE AND ELECTED TO HAVE THE LIGHT ADJUSTABLE LENS (LAL) EXPLANTED FROM THE RIGHT EYE. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25245285 ↗
• InjuryMay 14, 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 LEFT EYE DUE TO BLURRY DISTANCE VISION AND A NEW LAL IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 25175053 ↗
• 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), +20.0D) IN THE LEFT EYE ON (B)(6) 2023. THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS POST-OPERATIVELY BUT DID NOT COMPLETE THE NECESSARY LOCK IN TREATMENTS. THE PATIENT RETURNED TO CLINIC APPROXIMATELY 8 MONTHS LATER ON (B)(6) 2024, COMPLAINING OF BLURRY VISION. THE PATIENT COMPLETED 3 ADDITIONAL LIGHT ADJUSTMENTS WITH NO IMPROVEMENT. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE TREATING PHYSICIAN OBSERVED A MILD HAZE ON THE ANTERIOR SIDE OF THE LAL. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026 AND REPLACED WITH A MONOFOCAL IOL. VISUAL EXAMINATION OF THE EXPLANTED LENS FRAGMENTS CONFIRMED A CENTRAL IOL IRREGULARITY THAT IS CONSISTENT WITH PHOTOPOLYMERIZATION.

  Patient problems: Blurred Vision

  MAUDE report 24743633 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24721265 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) WAS EXPLANTED AND REPLACED WITH ANOTHER LAL (SN (B)(6), +20.0D).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24449061 ↗
• InjuryDec 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), +20.0D) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE POST-IMPLANTATION. THE LAL WAS REPLACED WITH ANOTHER LAL OF A DIFFERENT POWER (SN (B)(6), +16.5D).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23873596 ↗
• InjuryNov 25, 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 A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D). PROLAPSED VITREOUS WAS REMOVED AND THE LAL WAS SUCCESSFULLY PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23649828 ↗
• 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 A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D). A VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23609023 ↗
• InjuryNov 14, 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), +20.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 23556395 ↗
• 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), +20.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION.

  Patient problems: Blurred Vision

  MAUDE report 23548949 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +20.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH VISION QUALITY. THE TREATING PHYSICIAN NOTES POOR QUALITY OF VISION MAY BE DUE TO CORNEAL IRREGULARITIES AND PRE-EXISTING HIGHER ORDER ABERRATIONS PRESENT PRIOR TO CATARACT SURGERY.

  Patient problems: Blurred Vision

  MAUDE report 23487819 ↗
• InjuryAug 14, 2025Use of Device Problem; Use of Device Problem

  A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (B)(6) 2023. THE PATIENT HAD ONLY ONE LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS POSTOPERATIVELY. UPON RETURNING TO THE CLINIC ON (B)(6) 2025, THE PATIENT COMPLAINED OF BLURRY VISION. ON (B)(6) 2025, APPROXIMATELY 24 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT. AT THE TIME OF THE INTRAOCULAR LENS EXCHANGE, THE TREATING PHYSICIAN NOTED THAT THE EXPLANTED LENS WAS "DISTORTED".

  Patient problems: Blurred Vision

  MAUDE report 22806989 ↗
• InjuryJul 9, 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), +20.0D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL (SN: (B)(6), +20.0) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22460901 ↗
• 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 LIGHT ADJUSTABLE LENS (LAL, 70057600118, +20.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22342614 ↗
• InjuryJun 18, 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), +20.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL DISTURBANCE AND A NEW LAL (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22287285 ↗
• InjuryJun 13, 2025Use of Device Problem; Use of Device Problem

  A PHYSICIAN REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D). THE PATIENT HAD 2 LIGHT ADJUSTMENTS AND NO LOCK-IN PROCEDURES. THE PATIENT PRESENTED TO THE CLINIC APPROXIMATELY 2 YEARS AFTER IMPLANTATION COMPLAINING OF A CHANGE IN VISION. THE LAL WAS EXPLANTED. UPON EXPLANTATION OF THE LAL, THE SURGEON NOTED A CENTRAL CIRCULAR BUMP PRESENT ON THE LENS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22204130 ↗
• InjuryMay 30, 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), +20.0D) WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR AND VISUAL DISTURBANCES. A NEW LAL (SN (B)(6), +19.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22119339 ↗
• InjuryApr 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) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 21765730 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21149628 ↗
• InjuryJan 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), +20D) WAS EXPLANTED DUE TO THE PATIENT NOT BEING ABLE TO DILATE SUFFICIENTLY FOR LIGHT ADJUSTMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093288 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 20926867 ↗