RxSight Light Adjustable Lens (RxLAL) 60005-3195Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00818806020661), received between Nov 17, 2021 and Jun 30, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Scratched Material

  A SITE REPORTED TO RXSIGHT THAT, DURING A POSTOPERATIVE EXAMINATION, THE LIGHT ADJUSTABLE LENS (LAL) WAS OBSERVED TO HAVE A VISUALLY SIGNIFICANT SCRATCH THAT WAS BELIEVED TO HAVE OCCURRED DURING IMPLANTATION. THE LAL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25666740 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS IN THE LEFT EYE, THE LEADING HAPTIC TORE THE CAPSULAR BAG. THE LENS WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 25375562 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT IMPLANTED WITH LIGHT ADJUSTABLE LENS (LAL) IN THE LEFT EYE UNDERWENT A SECONDARY PROCEDURE AFTER ALL LIGHT TREATMENTS TO IMPLANT A NON-RXSIGHT SULCUS-FIXATED LENS TO CORRECT RESIDUAL REFRACTIVE ERROR AND BLURRY VISION. POSTOPERATIVELY, THE PATIENT COMPLAINED OF BLURRY VISION, LIGHT SENSITIVITY, AND VISUAL DISTURBANCES IN THE SETTING OF A DILATED PUPIL. THE SULCUS-FIXATED LENS WAS ALSO OBSERVED TO BE DECENTERED AND WAS LATER REPOSITIONED. THE PATIENT'S VISUAL DISTURBANCES PERSISTED SECONDARY TO PUPILLARY ISSUES DESPITE ATTEMPTED TREATMENT. FOLLOWING THIS, THE LAL WAS EXPLANTED.

  Patient problems: Visual Disturbances

  MAUDE report 25250411 ↗
• InjuryMay 18, 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 LEFT EYE. THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25202879 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(60, +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24538298 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) AND RECEIVED 3 ADJUSTMENT LIGHT TREATMENTS. FOLLOWING ADJUSTMENT #3, THE PATIENT COMPLAINED OF GHOSTING/MONOCULAR DIPLOPIA. THE TREATING PHYSICIAN STATED THE PUPIL DILATION WAS ASYMMETRIC AND BELIEVES MAY HAVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE LENS WAS EXPLANTED DUE TO MONOCULAR DIPLOPIA AND A NEW LAL (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 24508904 ↗
• InjuryJan 22, 2026Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS EXPLANTED FROM THE RIGHT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO A REFRACTIVE SURPRISE. A NEW LAL (SN (B)(6)) WITH A DIFFERENT POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 24148163 ↗
• InjurySep 2, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) ON (B)(6) 2022. THE PATIENT DID NOT RETURN TO THE CLINIC FOR LIGHT TREATMENTS. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2025 COMPLAINING OF VISUAL DISTURBANCES. ON (B)(6) 2025, APPROXIMATELY 32 MONTHS AFTER IMPLANT SURGERY, THE LAL WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND A NEW LAL (SN (B)(6), +19.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 22939211 ↗
• InjuryAug 18, 2025Use of Device Problem; Use of Device Problem

  A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) +19.50D) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE IN (B)(6) 2023. THE PATIENT HAD ONLY ONE LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS POSTOPERATIVELY. UPON RETURNING TO CLINIC ON (B)(6) 2025, THE PATIENT COMPLAINED OF BLURRY VISION. ON (B)(6) 2025, APPROXIMATELY 23 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT. AT THE TIME OF THE INTRAOCULAR LENS EXCHANGE, THE TREATING PHYSICIAN OBSERVED AN IRREGULAR OPTICAL SURFACE ON THE EXPLANTED LENS.

  Patient problems: Blurred Vision

  MAUDE report 22835660 ↗
• InjuryAug 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), +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO DISSATISFACTION WITH CHOSEN REFRACTIVE TARGET. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22806461 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +19.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCES. A NEW LAL (SN: (B)(6), +19.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22795148 ↗
• InjuryJul 22, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22565948 ↗
• InjuryJun 26, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.50D) ON (B)(6) 2022. THE PATIENT DID NOT COMPLETE THE REQUIRED LOCK-IN TREATMENTS AND DID NOT RETURN TO THE CLINIC FOR APPROXIMATELY 20 MONTHS. APPROXIMATELY 2 YEARS AND 7 MONTHS AFTER IMPLANTATION, THE PATIENT'S LAL WAS EXPLANTED DUE TO BLURRY VISION AND CLINICAL OBSERVATIONS INDICATING LIKELY ZONE FORMATION.

  Patient problems: Blurred Vision

  MAUDE report 22342659 ↗
• InjuryMar 31, 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), +22.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH UNCORRECTED DISTANCE VISUAL ACUITY AND A NEW LAL (SN (B)(6), +20.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21734853 ↗
• InjuryFeb 4, 2025Adverse 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 MODERATE OCULAR SURFACE AND LID DISEASE WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) IN THE LEFT EYE ON (B)(6) 2024. THE PATIENT PRESENTED APPROXIMATELY 5 MONTHS AFTER THE LIGHT DELIVERY DEVICE LOCK-IN 2 PROCEDURE COMPLAINING OF VISUAL DISTURBANCES AND PHOTOPHOBIA. THE PHYSICIAN ELECTED TO EXPLANT THE PATIENT'S LAL (SN (B)(6), +19.5D) ON (B)(6) 2025.

  Patient problems: Photophobia; Visual Disturbances

  MAUDE report 21305453 ↗
• InjuryNov 26, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) IN THE RIGHT EYE ON (B)(6) 2023. ONE LIGHT TREATMENT WAS PERFORMED ON (B)(6) 2023. NO FURTHER LIGHT TREATMENTS WERE COMPLETED. APPROXIMATELY 19 MONTHS AFTER IMPLANTATION, THE PATIENT RETURNED TO THE CLINIC COMPLAINING OF BLURRY VISION AND VISUAL DISTURBANCES. THE TREATING PHYSICIAN NOTED THAT THE LENS HAD CHANGED DUE TO PATIENT'S FAILURE TO RETURN FOR LOCK-IN TREATMENTS AND ELECTED TO EXCHANGE THE LAL WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5).

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20783066 ↗
• InjuryNov 26, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) IN THE LEFT EYE ON (B)(6) 2023. TWO LIGHT TREATMENTS WERE PERFORMED ON (B)(6) 2023. NO FURTHER LIGHT TREATMENTS WERE COMPLETED. APPROXIMATELY 19 MONTHS AFTER IMPLANTATION, THE PATIENT RETURNED TO THE CLINIC COMPLAINING OF BLURRY VISION AND VISUAL DISTURBANCES. THE TREATING PHYSICIAN NOTED THAT THE LENS HAD CHANGED DUE TO PATIENT'S FAILURE TO RETURN FOR LOCK-IN TREATMENTS AND ELECTED TO EXCHANGE THE LAL WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +19.5).

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20780815 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH DISTANCE AND NEAR VISION. A NEW LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +20.0D) WAS IMPLANTED AS A REPLACEMENT AND 16 DAYS AFTER LENS EXCHANGE, THE PATIENT IS REPORTED TO BE HAPPIER WITH THEIR VISION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 09/17/2024. REFERENCE REPORT #3012712027-2024-00177 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20454930 ↗
• InjurySep 6, 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), +19.5D), WHICH HAD ALREADY COMPLETED 3 ADJUSTMENT LIGHT TREATMENTS, WAS EXPLANTED AFTER THE PATIENT EXPERIENCED VISION CHANGES FOLLOWING SUPERFICIAL KERATECTOMY (SK) SECONDARY TO ANTERIOR BASEMENT MEMBRANE DYSTROPHY (ABMD). THE EYE SURGEON STATED THAT THE PATIENT'S VISUAL OUTCOME AFTER LIGHT TREATMENTS AND BEFORE SK WAS GOOD. AN LAL+ (SN (B)(6), +23.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 08/08/2024.

  Patient problems: Visual Impairment

  MAUDE report 20163720 ↗
• InjuryJun 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) WAS EXPLANTED FROM THE LEFT EYE (OS) AND ANOTHER LAL (+19.5D) WAS IMPLANTED AS A REPLACEMENT DUE TO A CHANGE IN DESIRED REFRACTIVE TARGET AFTER COMPLETION OF FULL LIGHT TREATMENT COURSE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 05/08/2024.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19469405 ↗
• 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 BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS ((B)(6)) WAS EXPLANTED FROM THE RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR. AN INTRAOCULAR LENS (B)(6) FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Visual Impairment

  MAUDE report 19288650 ↗
• InjuryMay 1, 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, A CAPSULAR BAG TEAR WAS NOTED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D); THE LENS WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 04/03/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19221998 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) WAS EXPLANTED FROM THE LEFT EYE (OS) DUE TO GHOSTING AND SHADOWING SECONDARY TO UNCORRECTED REFRACTIVE ERROR. A TORIC INTRA-OCULAR LENS FROM ANOTHER MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/21/2024. REFERENCE REPORT #3012712027-2024-00039 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18944320 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE DELIVERY OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D) INTO THE EYE, THE TRAILING HAPTIC WAS TORN. DURING REMOVAL OF THE LAL, A CAPSULE TEAR WAS NOTED. PLACEMENT OF A 2ND LAL (SN (B)(6), +19.5D) INTO THE CAPSULAR BAG WAS NOT SUCCESSFUL, LEADING TO ITS REMOVAL AND REPLACEMENT WITH A SULCUS FIXATED. MONOFOCAL 3-PIECE IOL. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 12/13/2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 18548313 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING DELIVERY OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.5D), A CAPSULAR TEAR OCCURRED. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LAL WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 11/10/2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 18242213 ↗