RxSight Light Adjustable Lens (RxLAL) 60005-3180Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00818806020630), received between Sep 20, 2022 and Sep 18, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 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 right eye (OD) due to blurred distance vision. Another LAL was implanted as a replacement.

  Patient problems: Blurred Vision

  MAUDE report 50818350 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISSATISFACTION WITH VISION AFTER COMPLETION OF LIGHT TREATMENTS.

  Patient problems: Insufficient Information

  MAUDE report 24916762 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +18.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24747876 ↗
• InjuryMar 17, 2026Adverse 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), +18.0D). THE LAL WAS EXPLANTED, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND ANOTHER 3 PIECE IOL WAS IMPLANTED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24623764 ↗
• InjuryJan 21, 2026Adverse 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), +18.0D). THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 24138045 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RXSIGHT WAS INFORMED THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) WAS IMPLANTED BACKWARDS ON (B)(6) 2025. THE SURGEON NOTED HAVING AN ISSUE WITH THE HAPTIC DURING SURGERY. THE LENS WAS SUCCESSFULLY FLIPPED TO THE CORRECT ORIENTATION WITHOUT COMPLICATIONS DURING A SECONDARY SURGERY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658802 ↗
• 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 PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), +18.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND DISSATISFACTION WITH VISION.

  Patient problems: Visual Disturbances

  MAUDE report 23608997 ↗
• InjurySep 19, 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), +18.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +18.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23097185 ↗
• InjurySep 17, 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), +18.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION. A NEW LAL (SN: (B)(6), +18.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23074614 ↗
• InjurySep 3, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO VISUAL CHANGES AFTER USE OF A TANNING BED WITHOUT RXSIGHT UV PROTECTIVE SPECTACLES PRIOR TO ANY LIGHT TREATMENTS BEING PERFORMED. CLINICAL EXAMINATION REVEALED A CENTRAL AREA OF ELEVATION ON THE LENS.

  Patient problems: Blurred Vision

  MAUDE report 22953584 ↗
• 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, SN (B)(6), +18.0D) WAS EXPLANTED FROM THEIR LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR.

  Patient problems: Visual Impairment

  MAUDE report 22891326 ↗
• InjuryAug 5, 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), +18.0D) WAS EXPLANTED DUE TO LENS DISLOCATION. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS NOTED TO HAVE RETAINED FRAGMENTS OF THE NATURAL CRYSTALLINE LENS.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22723046 ↗
• 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 CAPSULAR BAG TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), D). A VITRECTOMY WAS PERFORMED AND THE LAL WAS REPOSITIONED IN THE SULCUS WITH OPTIC CAPTURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22134308 ↗
• InjuryNov 6, 2024Optical Problem; Optical Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +18.0D) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2024 DURING PRIMARY CATARACT SURGERY. TWO LIGHT TREATMENTS WERE COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE CLINIC WITH SUDDEN ONSET BLURRY VISION IN THE RIGHT EYE AND WAS DIAGNOSED WITH MACULA-OFF RETINAL DETACHMENT. RETINAL DETACHMENT REPAIR WITH ENDOLASER AND SF6 WAS PERFORMED ON (B)(6) 2024. FOLLOWING RETINAL REPAIR SURGERY, ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS; A PARS PLANA VITRECTOMY WITH CULTURE AND SILICONE OIL TAMPONADE WERE PERFORMED ON THE SAME DAY. BACTERIAL CULTURES WERE NEGATIVE AS OF ON (B)(6) 2024. SUPERIOR DISPLACEMENT OF THE LAL WITH SILICONE OIL ON THE POSTERIOR SURFACE WAS NOTED ON (B)(6) 2024. ON (B)(6) 2024, THE SILICONE OIL WAS REMOVED. ON (B)(6) 2024, IT WAS NOTED THAT THE LAL WAS OPACIFIED WHEN OBSERVED UNDER SLIT LAMP. THE LAL (SN: (B)(6) WAS EXPLANTED ON (B)(6) 2024 AND REPLACED WITH AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER.

  Patient problems: Blurred Vision

  MAUDE report 20625996 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) DURING PRIMARY CATARACT SURGERY, THE LENS TILTED BACK AND IT WAS NOTED THAT THE POSTERIOR CAPSULE WAS NOT INTACT. THE LAL WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/26/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 20057082 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT UPON DELIVERY OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) INTO THE PATIENT'S EYE, A POSTERIOR CAPSULE TEAR WAS NOTED. AN ANTERIOR VITRECTOMY WAS PERFORMED, AND THE LAL WAS PLACED IN THE SULCUS. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/13/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 19680916 ↗
• InjuryJun 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AND A NEW LAL (SN (B)(6), +21.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Visual Impairment

  MAUDE report 19610877 ↗
• 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 BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) +18.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR VISION IN THE EYE AND ANOTHER LAL (SN (B)(6) +17.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2024.

  Patient problems: Blurred Vision

  MAUDE report 19055073 ↗
• InjuryMar 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) WAS EXPLANTED AND A NEW LAL (SN (B)(6), +4.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/20/2024.

  Patient problems: Visual Impairment

  MAUDE report 18954444 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RXSIGHT WAS INFORMED OF A REPORT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +18.0D) WAS IMPLANTED BACKWARDS IN THE LEFT EYE (OS) DURING PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS COMPLETED TO EXPLANT THE LAL AND IMPLANT A NEW LAL (SN: (B)(6), +18.0D) IN THE PROPER ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/01/2024. REFERENCE REPORT#: 3012712027-2024-00041 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18954128 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RXSIGHT WAS INFORMED OF A REPORT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +18.0D) WAS IMPLANTED BACKWARDS IN THE RIGHT EYE (OD) DURING PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS COMPLETED TO EXPLANT THE LAL AND IMPLANT A NEW LAL (SN (B)(6), +19.0D) IN THE PROPER ORIENTATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 02/20/2024. REFERENCE REPORT #3012712027-2024-00042 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18954102 ↗
• 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), +18.0D) WAS EXPLANTED FROM THE RIGHT EYE (OD) 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 02/19/2024. REFERENCE REPORT #3012712027-2024-00040 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18944310 ↗
• InjurySep 6, 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) , +18.0D) WAS EXPLANTED ON (B)(6) 2023 AND WAS REPLACED WITH ANOTHER LAL OF THE SAME DIOPTER. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/09/2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17695521 ↗
• InjuryMay 26, 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), +18.0D) WAS EXPLANTED ON (B)(6)2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17014462 ↗
• InjuryMay 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 18.0D) WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS BEING PERFORMED DUE TO THE PATIENT HAVING AN UNEXPECTED HYPEROPIC OUTCOME POST OP. THE INITIAL LAL WAS EXPLANTED ON (B)(6) 2023, AND WAS REPLACED WITH ANOTHER LAL (SN (B)(6), 23.0D). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023. THIS PATIENT WAS BILATERALLY IMPLANTED AND EXPLANTED. REFERENCE MDR 3012712027-2023-00033 FOR THE REPORT ON THE OTHER EYE.

  Patient problems: Visual Impairment

  MAUDE report 16900014 ↗