RxSight Light Adjustable Lens (RxLAL) 60005-3240Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00818806020753), received between Feb 8, 2021 and Jul 1, 2026 — classified as 19 injuries, 1 malfunction.

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 20 most recent of 20 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'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO DECREASED VISION AFTER THREE LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS; ANOTHER LAL WAS IMPLANTED AS A REPLACEMENT. THE DECREASED VISION REPORTEDLY BEGAN DURING A HOSPITALIZATION FOR PNEUMONIA AND WAS CHARACTERIZED BY BLURRED DISTANCE VISION AND GHOSTING WHILE DRIVING. THE PATIENT ALSO REPORTED TO THE SITE A HISTORY OF TANNING BED USE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25681657 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL), A TEAR OCCURRED IN THE POSTERIOR CAPSULAR BAG, LIKELY CAUSED BY THE LEADING HAPTIC DURING LENS DELIVERY. THE LAL WAS SUBSEQUENTLY REPOSITIONED IN THE SULCUS WITH OPTIC CAPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25536684 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL), THE LEADING HAPTIC BROKE THE CAPSULAR BAG. THE LAL WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. NO VITRECTOMY WAS NEEDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25478133 ↗
• MalfunctionMar 26, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6),+24.0D) WAS IMPLANTED BACKWARDS DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702001 ↗
• InjuryMar 13, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) ON (B)(6) 2023. TWO LIGHT ADJUSTMENTS WERE COMPLETED; HOWEVER, THE PATIENT DID NOT RETURN FOR THE LOCK-IN LIGHT TREATMENTS. APPROXIMATELY TWO YEARS LATER, DURING AN EXAM ON (B)(6) 2025, THE PATIENT REPORTED BLURRY VISION. AN ADDITIONAL LIGHT ADJUSTMENT WAS PERFORMED ON (B)(6) 2025 AND THE PATIENT SUBSEQUENTLY COMPLETED THE LOCK-IN LIGHT TREATMENTS, HOWEVER, THE SYMPTOMS PERSISTED. THE PATIENT SELF-REPORTED THAT THEY WERE NOT COMPLIANT WITH THE UV SPECTACLES WHILE WORKING ON A BOAT. THE PHYSICIAN NOTED REFRACTIVE CHANGES CONSISTENT WITH POLYMERIZATION AND THE LAL WAS EVENTUALLY EXPLANTED ON (B)(6) 2026. A NEW LAL+ (SN (B)(6), +24.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24590876 ↗
• InjuryMar 13, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0 D) ON (B)(6) 2023. TWO LIGHT ADJUSTMENTS WERE COMPLETED; HOWEVER, THE PATIENT DID NOT RETURN FOR THE LOCK-IN LIGHT TREATMENTS. APPROXIMATELY TWO YEARS LATER, DURING AN EXAM ON (B)(6) 2025, THE PATIENT REPORTED BLURRY VISION. AN ADDITIONAL LIGHT ADJUSTMENT WAS PERFORMED ON (B)(6) 2025 AND THE PATIENT SUBSEQUENTLY COMPLETED THE LOCK-IN LIGHT TREATMENTS, HOWEVER, THE SYMPTOMS PERSISTED. THE PATIENT SELF-REPORTED THAT THEY WERE NOT COMPLIANT WITH THE UV SPECTACLES WHILE WORKING ON A BOAT. THE PHYSICIAN NOTED REFRACTIVE CHANGES CONSISTENT WITH POLYMERIZATION AND THE LAL WAS EVENTUALLY EXPLANTED ON (B)(6) 2026. A NEW LAL+ (SN (B)(6), +24.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24590875 ↗
• InjuryJan 15, 2026Optical Decentration; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) WAS IMPLANTED ON (B)(6) 2024. THE PATIENT COMPLETED 1 LIGHT ADJUSTMENT DURING THE POST-OPERATIVE TIME AND DID NOT RETURN TO THE CLINIC FOR LOCK-IN TREATMENTS. APPROXIMATELY 17 MONTHS AFTER IMPLANTATION, ON (B)(6) 2025, THE PATIENT PRESENTED IN CLINIC COMPLAINED OF SIGNIFICANT VISUAL ACUITY DECLINE IN THE PAST 3 WEEKS. ITRACE WAS PERFORMED AND CONFIRMED PRESENCE OF LENS ABERRATION SECONDARY TO NO LOCK IN BEING PERFORMED. IOL SUBLUXATION WAS ALSO NOTED. ON (B)(6) 2025, THE LENS WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24080812 ↗
• InjuryJan 14, 2026Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AFTER IMPLANTATION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24069945 ↗
• InjuryDec 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +24.0D) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE AFTER IMPLANTATION. THREE ADJUSTMENTS WERE PERFORMED PRIOR TO EXPLANT IN ATTEMPT TO REDUCE THE REFRACTIVE ERROR. A NEW LAL (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 23830088 ↗
• InjuryJul 15, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, MODEL (B)(6), +24.0D) WAS EXPLANTED DUE TO BLURRY VISION FOLLOWING EXPOSURE TO ULTRAVIOLET (UV) LIGHT FROM TANNING BED USE. THE PATIENT DID NOT COMPLETE LIGHT TREATMENTS. A REPLACEMENT LAL WAS SUBSEQUENTLY IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 22510031 ↗
• 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 LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET. A NEW LAL (SN (B)(6)) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22286702 ↗
• InjuryFeb 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A HISTORY OF PAST CORNEAL SURGERIES, INCLUDING RK AND AK, WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) ON (B)(6) 2024. AFTER IMPLANTATION AND PRIOR TO ANY LIGHT TREATMENTS ON (B)(6) 2024, THE PATIENT'S MANIFEST REFRACTION WAS +3.75 +1.50 X148 AND BEST-CORRECTED DISTANCE VISUAL ACUITY WAS 20/20. THE LAL WAS EXPLANTED ON (B)(6) 2025 DUE TO THE INCORRECT DIOPTER POWER INITIALLY CHOSEN AND ANOTHER MANUFACTURER'S IOL OF +30.0D POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21305628 ↗
• InjuryNov 6, 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 A HISTORY OF PRIOR LASIK AND PRK AND WITH SIGNIFICANT DRY EYE THAT REQUIRED PUNCTAL CAUTERY WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) ON (B)(6) 2024. THE PATIENT SUCCESSFULLY COMPLETED ALL LIGHT TREATMENTS ON (B)(6) 2024. TEN DAYS LATER, THE PATIENT UNDERWENT EMERGENCY ABDOMINAL SURGERY. ONE WEEK AFTER THE ABDOMINAL SURGERY, ON (B)(6) 2024, THE PATIENT RETURNED TO THE EYE CARE PROFESSIONAL'S OFFICE COMPLAINING OF BLURRY VISION AND VISUAL DISTURBANCES EVEN THOUGH UNCORRECTED DISTANCE VISUAL ACUITY WAS 20/20 AND MANIFEST REFRACTION WAS -0.75 +0.50 X136. THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +24.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20624311 ↗
• InjuryJun 13, 2024Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) WAS DISLOCATED DURING THE POST-OPERATIVE PERIOD DUE TO A LARGER THAN NORMAL CAPSULORHEXIS AND NEEDED TO BE EXPLANTED. ANOTHER LAL (SN (B)(6), +23.5D) WAS IMPLANTED INTO THE SULCUS.

  Patient problems: Visual Impairment

  MAUDE report 19534261 ↗
• InjuryMay 10, 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 (B)(6) WAS EXPLANTED ON (B)(6)2024. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19288240 ↗
• InjuryMar 12, 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), +24.0D) 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), +24.0D) IN THE CORRECT ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/13/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18887333 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING HALOS. THE ORIGINAL LAL WAS EXPLANTED AND REPLACED WITH A NEW LAL (SN (B)(6), +24.0D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Halo

  MAUDE report 17569256 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE HAS REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +24.0D) WAS IMPLANTED ON (B)(6) 2023. DURING A POST-OPERATIVE VISIT, A POSTERIOR CAPSULAR TEAR WAS OBSERVED IN THE PATIENT'S EYE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 16923748 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT DURING THE IMPLANT PROCEDURE FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 24.0D) A CAPSULAR BAG TEAR OCCURRED. THE SURGEON PERFORMED A VITRECTOMY AND PLACED THE LAL IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 16916518 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED THAT AS THE LENS WAS REPOSITIONED IN THE EYE, A SMALL POSTERIOR CAPSULAR RUPTURE DEVELOPED. THERE WAS NO VITREOUS LOSS. THE LAL WAS IMPLANTED SUCCESSFULLY. THE PHYSICIAN NOTED THAT THE CAPSULAR BAG WAS "FRAGILE AND THIN."

  Patient problems: Capsular Bag Tear

  MAUDE report 11295359 ↗