RxSight Light Adjustable Lens (RxLAL) 60005-2230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00818806020234), received between Jun 5, 2020 and Nov 23, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Optical Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO PATIENT NON-COMPLIANCE WITH UV PROTECTION WHICH LED TO AN AMBIENT ZONE FORMATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15857560 ↗
• InjuryNov 17, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO SUSPECTED AMBIENT ZONE FORMATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 11/04/2022.

  Patient problems: Visual Impairment

  MAUDE report 15811758 ↗
• InjurySep 2, 2022Optical Distortion; Optical Distortion

  SITE REPORTED THE PATIENT HAD BILATERAL LIGHT ADJUSTABLE LENSES IMPLANTATION. LEFT EYE (OS) WAS IMPLANTED ON (B)(6) 2021. RIGHT EYE (OD) WAS IMPLANTED ON (B)(6) 2021. PATIENT PROCEEDED TO HAVE THEIR 1ST LIGHT TREATMENT. AFTER THE 1ST LIGHT TREATMENT, FOR A PROLONGED PERIOD OF TIME THE PATIENT WAS UNABLE TO RETURN TO THE CLINIC FOR REQUIRED FOLLOW-UP LIGHT TREATMENTS DUE TO UNRELATED ILLNESS AND HOSPITALIZATION. PATIENT RETURNED TO THE CLINIC ON (B)(6) 2022 AND COMPLAINED OF BLURRY VISION. UPON FURTHER EXAMINATION, THE TREATING PHYSICIAN OPTED TO PERFORM AN EXCHANGE. THE LIGHT ADJUSTABLE LENSE FOR THE RIGHT EYE (OD) WAS EXPLANTED ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15353165 ↗
• InjuryDec 9, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AS THE PATIENT DID NOT RETURN FOR ANY LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12969830 ↗
• InjuryNov 18, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12838185 ↗
• InjuryMay 14, 2021Optical Problem; Optical Problem

  SITE REPORTED POST-LASIK PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2020, WITH LIGHT TREATMENTS COMPLETED IN (B)(6) 2020. UPON RETURN TO CLINIC IN (B)(6) 2020, BEST CORRECTED VISUAL ACUITY WAS 20/25. THE LAL WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 11826178 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SITE REPORTED THAT THE PATIENT WAS DISSATISFIED WITH VISION. THE DOCTOR AIMED FOR MONOVISION, HOWEVER, THE PATIENT WANTED DISTANCE VISION FOR BOTH EYES. THE LENS WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 11569323 ↗
• InjuryMar 8, 2021Optical Distortion; Optical Distortion

  BILATERAL PATIENT REPORTED A DECREASE IN VISION IN BOTH EYES AND NON-COMPLIANCE WITH UV SPECTACLE WEAR. THE DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF BOTH LENSES. ONE LENS WAS EXCHANGED ON (B)(6) 2021 AND THE SECOND LENS EXCHANGE OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 11440565 ↗
• InjuryJun 5, 2020Optical Distortion; Optical Distortion

  PATIENT WITH A LIGHT ADJUSTABLE LENS IN THE RIGHT EYE REPORTED BLURRY VISION, GLARE, AND DRYNESS. UPON EXAMINATION, A CENTRAL ISLAND WAS NOTED NEAR THE CENTER OF THE LENS, WHICH IS INDICATIVE OF EXPOSURE TO UV LIGHT. UPON FOLLOW-UP IT WAS NOTED THAT THE PATIENT WAS NOT COMPLIANT WITH UV SPECTACLE WEAR. THE LENS WAS EXPLANTED ON (B)(6) 2020. THE EXPLANTED LENS IS IN PROCESS OF BEING RETURNED.

  Patient problems: Visual Disturbances

  MAUDE report 10124048 ↗