RxSight Light Adjustable Lens (RxLAL) 60005-3150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818806020593), received between Aug 11, 2022 and Sep 28, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Optical Problem” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 50916564 ↗
• InjuryJun 9, 2026Adverse 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 AFTER COMPLETION OF 2 LIGHT ADJUSTMENTS.

  Patient problems: Visual Impairment

  MAUDE report 25449314 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +15.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2025. POSTOPERATIVELY AND PRIOR TO LIGHT TREATMENTS, THE PATIENT COMPLAINED OF VISUAL DISTURBANCES. AFTER THE COMPLETION OF LIGHT TREATMENTS, THE PATIENT CONTINUED TO REPORT VISUAL DISTURBANCES. THE LAL WAS EXPLANTED (B)(6) 2026.

  Patient problems: Visual Disturbances

  MAUDE report 24794811 ↗
• MalfunctionApr 6, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +15.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE SURGEON SUCCESSFULLY FLIPPED THE LENS TO THE CORRECT ORIENTATION DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790377 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +15.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISUAL DISTURBANCES. THE TREATING PHYSICIAN NOTED THERE WAS AN OPACITY UNDER THE ANTERIOR IOL SURFACE. A NEW LAL (SN (B)(6), +14.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24235002 ↗
• InjuryDec 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), +15.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AND A NEW LAL (SN (B)(6), +12.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 23829714 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING DELIVERY OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +15.0D) A CAPSULE TEAR OCCURRED. THE LAL WAS REMOVED FROM THE EYE AND AN ANTERIOR VITRECTOMY PERFORMED. A NEW LAL (SN (B)(6), +15.0D) WAS IMPLANTED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22717427 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD HER RIGHT EYE (OD) LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +15.0D) EXPLANTED DUE TO PATIENT DISSATISFACTION. THE EXPLANTED LAL WAS REPLACED WITH ANOTHER LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023. REFERENCE MDR 3012712027-2023-00057 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Impairment

  MAUDE report 17195475 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT ON (B)(6) 2023 DURING THE IMPLANT PROCEDURE FOR A LIGHT ADJUSTABLE LENS (LAL, (B)(4) 15.0D) A CAPSULAR BAG TEAR OCCURRED. THE SURGEON PERFORMED A LIMITED VITRECTOMY AND PLACED THE LAL IN THE SULCUS. AT A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2023, THE PATIENT'S UNCORRECTED DISTANCE VISUAL ACUITY WAS 20/20. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 16965542 ↗
• InjuryOct 12, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED FROM THE PATIENT DUE TO UNEXPECTED REFRACTIVE OUTCOME AND SHIFT IN LENS POSITION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 09/12/2022.

  Patient problems: Visual Impairment

  MAUDE report 15591237 ↗
• 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 (B)(6) 2022. THE RIGHT EYE UNDERWENT ONE ADJUSTMENT AND DID NOT COMPLETE REQUIRED LIGHT TREATMENTS. THE RIGHT EYE'S LAST AVAILABLE REFRACTION AND VISUAL ACUITY ON (B)(6) 2022 WAS "PLANO 20/25". 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 RIGHT EYE WAS CONFIRMED TO HAVE BEEN COMPLETED ON (B)(6) 2022. REFER TO MFR REPORT #: 3012712027-2022-00040 FOR INFORMATION ON THE PATIENT'S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 15442888 ↗
• InjuryAug 11, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT CHANGED THEIR DESIRED REFRACTIVE OUTCOME AFTER LOCK-IN. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15214420 ↗