RxSight Light Adjustable Lens (RxLAL) 60005-3140Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00818806020586), received between Sep 16, 2022 and Jul 27, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient Device Interaction Problem

  A site reported to RxSight that temporal zonular dehiscence was noted during implantation of a Light Adjustable Lens (LAL). The implanting surgeon reported that the zonular dehiscence precluded successful implantation of the LAL because the lens could not be rotated. The surgeon completed the surgery, leaving the trailing haptic in the sulcus, and the optic and leading haptic within the capsular bag. Postoperatively, the patient was referred to a retinal surgeon. A secondary surgical procedure was subsequently performed to explant the dislocated LAL and implant a non-RxSight intraocular lens (IOL) via scleral fixation. A surgical peripheral iridotomy was also performed during the procedure. No additional information is available.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50046886 ↗
• InjuryJul 1, 2026Malposition of Device

  A SITE REPORTED TO RXSIGHT THAT THE LEADING HAPTIC CAUSED A SMALL TEAR IN THE POSTERIOR CAPSULE DURING DELIVERY OF THE LIGHT ADJUSTABLE LENS (LAL). THE LAL WAS SUBSEQUENTLY PLACED IN THE SULCUS. POSTOPERATIVELY, THE LEADING HAPTIC WAS FOUND TO BE UNSECURED IN THE SULCUS. A SECONDARY PROCEDURE WAS PERFORMED IN WHICH THE LEADING HAPTIC WAS REPOSITIONED INTO THE SULCUS, AND AN ANTERIOR VITRECTOMY WAS COMPLETED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25681651 ↗
• InjuryJun 5, 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 LEFT EYE DUE TO MONOCULAR DIPLOPIA AND GHOSTING. A STANDARD MONOFOCAL LENS TARGETING EMMERTROPIA/DISTANCE VISION WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS REPORTED TO BE DOING WELL POSTOPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 25408834 ↗
• InjuryAug 29, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS IMPLANTED ON (B)(6) 2025 USING THE YAMANE TECHNIQUE. DUE TO DISLOCATION OF THE LENS POSTOPERATIVELY, THE LAL WAS REPOSITIONED ON (B)(6) 2025. THE LENS AGAIN DISLOCATED POSTOPERATIVELY AND WAS REPOSITIONED IN (B)(6) 2025; IN ADDITION, CAUTERIZATION OF A HAPTIC WAS PERFORMED DURING THE PROCEDURE. ON (B)(6) 2025 THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +14.0D) IMPLANTED USING YAMANE WITH SCLERAL GRAFT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22926020 ↗
• InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS DUE TO A REFRACTIVE SURPRISE POST-IMPLANTATION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22923635 ↗
• InjuryMay 16, 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), +14.0D) WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS DUE TO A REFRACTIVE SURPRISE POST-IMPLANTATION. THE LAL WAS REPLACED WITH ANOTHER LAL OF A DIFFERENT POWER (SN (B)(6), +21.5D).

  Patient problems: Visual Impairment

  MAUDE report 22040081 ↗
• InjuryFeb 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS DUE TO AN INCORRECT INTRAOCULAR LENS POWER SELECTION. THE LAL WAS REPLACED WITH ANOTHER LAL OF A DIFFERENT POWER (SN (B)(6), +25.0D).

  Patient problems: Visual Impairment

  MAUDE report 21473194 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) ON (B)(6) 2023 AND ALL REQUIRED LIGHT TREATMENTS WERE COMPLETED BY (B)(6) 2023. ACCORDING TO DATA OBTAINED FROM THE LIGHT DELIVERY DEVICE (LDD) ON (B)(6) 2023, THE EYE WAS LEFT WITH MODERATE COMPOUND HYPEROPIC ASTIGMATISM. THE PATIENT THEN PRESENTED TO THE CLINIC MORE THAN 1 YEAR LATER COMPLAINING OF BLURRY VISION. THE LAL WAS EXPLANTED AND REPLACED WITH AN LAL OF A DIFFERENT POWER (SN (B)(6), +18.0D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 09/04/2024.

  Patient problems: Blurred Vision

  MAUDE report 20368602 ↗
• InjurySep 13, 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), +14.0D) WAS EXPLANTED AFTER THE COMPLETION OF THE ENTIRE LIGHT TREATMENT COURSE DUE TO UNEXPECTED CYLINDER AS A RESULT OF A TOPOGRAPHY-GUIDED PHOTOREFRACTIVE KERATECTOMY (PRK), PERFORMED TO ADDRESS A PRE-EXISTING CORNEAL SCAR. A NEW LAL (SN (B)(6), +16.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/16/2024.

  Patient problems: Visual Impairment

  MAUDE report 20216459 ↗
• InjuryJul 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) PRESENTED WITH A +3.00D POSTOPERATIVE REFRACTIVE SURPRISE DUE TO THE PATIENT'S IRREGULAR CORNEA (HISTORY OF KERATOCONUS) PRIOR TO THE FIRST LIGHT TREATMENT. THE LAL WAS EXPLANTED ON (B)(6) 2024, AND ANOTHER LAL (SN (B)(6), +17.5D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/12/2024.

  Patient problems: Visual Impairment

  MAUDE report 19705080 ↗
• InjuryApr 25, 2024Adverse 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 ON (B)(6)2024 DUE TO THE PATIENT'S COMPLAINT OF SUPERIMPOSED IMAGES. FIVE DAYS FOLLOWING REPLACEMENT WITH A MONOFOCAL IOL, THE PATIENT'S SYMPTOMS WERE NOT RESOLVED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2024.

  Patient problems: Visual Disturbances

  MAUDE report 19186654 ↗
• InjuryApr 5, 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) , +14.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION AND ANOTHER LAL (SN (B)(6) , +13.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/06/2024.

  Patient problems: Blurred Vision

  MAUDE report 19055829 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +14.0D) WAS EXPLANTED DUE TO A MISCALCULATION OF POWER AND A NEW LAL (SN: (B)(6), +16.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON OCTOBER 23, 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18187191 ↗
• InjuryOct 25, 2023Optical Decentration; Optical Decentration

  THE SITE REPORTED THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS DECENTERED. THE TREATING PHYSICIAN BELIEVES THE HAPTIC MAY HAVE BEEN DAMAGED WHEN REMOVING AN IRIS RING FROM THE EYE DURING THE PRIMARY SURGERY. AFTER ATTEMPTING TO REPOSITION THE LENS AT THE SLIT LAMP, THE SURGEON DETERMINED IT WAS NECESSARY TO PERFORM AN EXCHANGE OF THE LAL IN THE OR, WHICH OCCURRED ON (B)(6) 2023. ANOTHER LAL (+14.0D) WAS PLACED INTO THE SULCUS. A LIMITED VITRECTOMY WAS ALSO PERFORMED DURING THE SAME SURGERY.

  Patient problems: Visual Disturbances

  MAUDE report 18008003 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +14.0D) WAS IMPLANTED INTO THE PATIENT'S EYE BACKWARDS; THE SURGEON NOTED A CAPSULAR BAG TEAR. WHILE ATTEMPTING TO REPOSITION THE LAL, THE TRAILING HAPTIC SEPARATED FROM THE OPTIC BODY. THE SURGEON REMOVED THE ORIGINAL LAL AND IMPLANTED A BACKUP LAL (+14.0D) IN THE SULCUS. A VITRECTOMY WAS NOT PERFORMED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 17971241 ↗
• InjuryAug 10, 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) +14.0D) A CAPSULAR BAG TEAR OCCURRED. THE SURGEON PERFORMED AN ANTERIOR VITRECTOMY AND PLACED THE LAL IN THE SULCUS. THE INCISION WAS CLOSED WITH ONE SUTURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 17505353 ↗
• InjuryApr 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED LIGHT ADJUSTABLE LENS (LAL) PATIENT HAD THEIR LENSES EXPLANTED DUE TO HAVING LARGE REFRACTIVE ERRORS. THE MANIFEST REFRACTION (MR) FOR THE RIGHT EYE POSTOPERATIVELY WAS +3.00 -1.25 X035, AND THE MR FOR THE LEFT EYE POSTOPERATIVELY WAS +3.25 -1.50 X090. THE EXPLANTED LALS WERE REPLACED WITH NEW LALS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 03/07/2023. THE LAL THAT WAS EXPLANTED FROM THE RIGHT EYE (OD) HAS SERIAL NUMBER SN (B)(4) (+14.0D). REFER TO MFR REPORT #: 3012712027-2023-00028 FOR INFORMATION ON THE PATIENT'S LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 16696702 ↗
• InjuryMar 24, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), +14.0D) WAS EXPLANTED DUE TO BEING IMPLANTED BACKWARDS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/23/2023.

  Patient problems: Visual Impairment

  MAUDE report 16616074 ↗
• InjurySep 16, 2022Optical Distortion; Optical Distortion

  SITE REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF LASIK SURGERY FOR BOTH EYES WAS IMPLANTED WITH LIGHT ADJUSTABLE LENSES (LAL) IN BOTH EYES. RIGHT EYE WAS IMPLANTED (B)(6) 2022. LEFT EYE WAS IMPLANTED 06/23/2022. THE LEFT EYE UNDERWENT TWO ADJUSTMENTS AND DID NOT COMPLETE REQUIRED LIGHT TREATMENTS. THE LEFT EYE'S LAST AVAILABLE REFRACTION AND VISUAL ACUITY ON (B)(6) 2022 WAS "-0.25 SPHERE 20/25 +2". PRIOR TO COMPLETING THE REQUIRED LIGHT TREATMENTS, THE PATIENT COMPLAINED OF GLARE AND DEMANDED AN IOL EXCHANGE. RXSIGHT'S FIRST AWARENESS DATE WAS (B)(6) 2022. ON (B)(6) 2022, THE IOL EXCHANGE FOR THE LEFT EYE WAS CONFIRMED TO HAVE BEEN COMPLETED ON (B)(6) 2022. REFER TO MFR REPORT #: 3012712027-2022-00039 FOR INFORMATION ON THE PATIENT'S RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 15442887 ↗