RxSight Light Adjustable Lens (RxLAL) 60005-3160Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818806020821), received between Dec 14, 2022 and Jun 9, 2026 — classified as 18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 FROM THE LEFT EYE DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET AFTER COMPLETION OF 3 LIGHT ADJUSTMENTS.

  Patient problems: Visual Impairment

  MAUDE report 25449315 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT AFTER IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL) IN THE LEFT EYE, THE PATIENT COMPLAINED OF VISUAL DISTURBANCES POSTOPERATIVELY AND PRIOR TO LIGHT TREATMENTS. AFTER COMPLETION OF LIGHT TREATMENTS, THE PATIENT CONTINUED TO EXPERIENCE VISUAL DISTURBANCES. THE LAL WAS EXPLANTED. FOLLOWING EXPLANTATION OF THE LAL, THE PATIENT'S SYMPTOMS RESOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 25262768 ↗
• InjuryMay 13, 2026Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT AN ANTERIOR CAPSULE TEAR WAS OBSERVED DURING THE PHACOEMULSIFICATION AND CORTEX REMOVAL STAGE OF THE CATARACT SURGERY. AS A RESULT, THE LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED INTO SULCUS. HOWEVER, DURING THE 1-DAY POST-OPERATIVE CHECK, IT WAS DISCOVERED THAT ONE OF THE HAPTICS GOT CAUGHT IN THE ANTERIOR CAPSULE TEAR AND THE LAL SUBLUXATED. A SECONDARY SURGERY WAS COMPLETED ON (B)(6) /2026 TO REPOSITION THE LENS INTO THE SULCUS WITH CORNEAL INCISION. NO VITRECTOMY WAS NEEDED. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161413 ↗
• InjuryMay 1, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO BEING IMPLANTED BACKWARDS DURING THE INITIAL IMPLANTATION SURGERY. IT WAS DETERMINED THAT THE LENS WAS IMPLANTED BACKWARDS AFTER 2 LIGHT TREATMENTS WERE COMPLETED AND THE PATIENT COMPLAINED OF DIPLOPIA. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Diplopia/Double Vision

  MAUDE report 25060325 ↗
• InjuryMar 26, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) IN THE LEFT EYE ON (B)(6) 2023. POST-OPERATIVELY, THE PATIENT COMPLETED 1 LIGHT ADJUSTMENT AND DID NOT RETURN TO THE CLINIC UNTIL APPROXIMATELY 1 YEAR LATER ((B)(6) 2024). UPON RETURNING TO THE CLINIC, THE PATIENT COMPLAINED OF BLURRED DISTANCE VISION AND SUBSEQUENTLY COMPLETED 2 ADDITIONAL LIGHT ADJUSTMENTS, WHICH BROUGHT THE PATIENT'S UNCORRECTED DISTANCE VISUAL ACUITY TO 20/20 AND MANIFEST REFRACTION TO PLANO SPHERE. NO LOCK-IN LIGHT TREATMENTS WERE COMPLETED. THE PATIENT CONTINUED TO COMPLAIN OF BLURRY DISTANCE VISION AND DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE PHYSICIAN NOTED A CENTRAL OPACIFICATION ON THE LAL. THE LAL WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2026.

  Patient problems: Blurred Vision

  MAUDE report 24702428 ↗
• InjuryMar 6, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D). ON POSTOPERATIVE EXAM, THE LAL WAS NOTED TO BE DECENTERED. A SECONDARY PROCEDURE WAS SUCCESSFULLY PERFORMED (B)(6) 2026 TO REPOSITION THE LAL.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24538131 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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), +16.0D). A VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 23771507 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) ON (B)(6) 2024. TEN DAYS LATER, THE LAL WAS EXPLANTED PRIOR TO ANY LIGHT TREATMENTS BEING PERFORMED DUE TO THE PATIENT CHANGING THEIR MIND ABOUT THEIR VISUAL GOALS.

  Patient problems: Blurred Vision

  MAUDE report 21707830 ↗
• InjuryFeb 18, 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) , +16.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21401472 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT DURING THE IMPLANT PROCEDURE FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 16.0D), A POSTERIOR CAPSULAR BAG TEAR OCCURRED. THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 20787698 ↗
• InjuryAug 14, 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), +16.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRED VISION AND DIPLOPIA. A NEW LAL (SN (B)(6), +16.5D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/27/2024. REFERENCE REPORT #3012712027-2024-00136 FOR THE REPORT ON THE LEFT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 19988400 ↗
• InjuryJul 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION AND THE PATIENT'S DISSATISFACTION WITH THEIR VISION AFTER 2 LIGHT DELIVERY DEVICE LIGHT TREATMENTS. THE SITE REPLACED THE EXPLANTED LENS WITH A NEW LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/26/2024.

  Patient problems: Blurred Vision

  MAUDE report 19823361 ↗
• InjuryOct 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PHYSICIAN REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +16.0D) EXPLANTED FROM THE RIGHT EYE (OD) DUE TO A REFRACTIVE SURPRISE AFTER IMPLANTATION AND LIGHT TREATMENTS. THE EXPLANTED LAL WAS REPLACED WITH A LAL OF A DIFFERENT POWER (SN: (B)(6), +22.5D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 10/03/2023. REFERENCE MDR 3012712027-2023-00093 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Impairment

  MAUDE report 18035048 ↗
• InjuryOct 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PHYSICIAN REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) EXPLANTED FROM THE LEFT EYE (OS) DUE TO A REFRACTIVE SURPRISE AFTER IMPLANTATION AND LIGHT TREATMENTS. THE EXPLANTED LAL WAS REPLACED WITH A LAL OF A DIFFERENT POWER (SN (B)(6), +26.0D). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 10/03/2023. REFERENCE MDR 3012712027-2023-00094 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Impairment

  MAUDE report 18035037 ↗
• InjuryMay 26, 2023Optical Decentration; Optical Decentration

  THE SITE REPORTED THAT ON (B)(6) 2023 DURING THE IMPLANT PROCEDURE FOR A LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +16.0D), A CAPSULAR BAG TEAR OCCURRED. THE SURGEON NOTED THE ENTIRE LENS WAS IN THE BAG BUT DECENTERED NASALLY BY ABOUT 2-3 MM. NO VITREOUS LOSS WAS OBSERVED. AT A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2023, THE PATIENT'S VISION WAS REPORTED TO BE 20/20 WITH MANIFEST REFRACTION BEING +0.50 +0.50 X180; HOWEVER, THE PATIENT REPORTS DYSPHOTOPSIA AND DIPLOPIA. ON (B)(6) 2023, THE SURGEON PERFORMED A REPOSITIONING OF THE LAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 04/27/2023.

  Patient problems: Capsular Bag Tear; Visual Disturbances

  MAUDE report 17014426 ↗
• InjuryApr 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), +16.0D) WAS EXPLANTED ON (B)(6) 2023 AND A NEW LAL WAS IMPLANTED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Disturbances

  MAUDE report 16820060 ↗
• 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 (B)(6) 2023. THE LAL THAT WAS EXPLANTED FROM THE LEFT EYE (OS) HAS SERIAL NUMBER SN (B)(4). (+16.0D). REFER TO MFR REPORT #: 3012712027-2023-00027 FOR INFORMATION ON THE PATIENT'S RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 16696743 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO A CAPSULAR BAG TEAR DURING THE IMPLANT SURGERY. THE IMPLANT SURGERY AND THE CAPSULAR BAG TEAR OCCURRED ON (B)(6) 2022 . THE LENS WENT INTO THE VITREOUS AND WAS LATER EXPLANTED BY A RETINAL SPECIALIST ON (B)(6) 2022 . RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022 .

  Patient problems: Capsular Bag Tear

  MAUDE report 15983751 ↗