RxSight Light Adjustable Lens (RxLAL) 60005-2195Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818806020166), received between Jul 22, 2020 and Jul 7, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Optical Distortion” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 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), +19.5D) WAS EXPLANTED ON (B)(6)2023 DUE TO PATIENT DISSATISFACTION. THE LAL WAS ORIGINALLY IMPLANTED ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023. REFERENCE MDR 3012712027-2023-00047 FOR THE REPORT ON THE RIGHT EYE (OD).

  Patient problems: Visual Impairment

  MAUDE report 17282966 ↗
• InjuryNov 4, 2021Optical Distortion; Optical Distortion

  SITE REPORTED BILATERAL PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED (B)(6) 2021; LEFT EYE EXPLANTED (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 10/8/2021.

  Patient problems: Visual Disturbances

  MAUDE report 12752244 ↗
• InjuryNov 1, 2021Optical Distortion; Optical Distortion

  SITE REPORTED THE PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. SUSPECTED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 12733927 ↗
• InjurySep 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT DUE TO DYSPHOTOPSIA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/17/2021.

  Patient problems: Visual Impairment

  MAUDE report 12465037 ↗
• InjuryAug 25, 2021Optical Distortion; Optical Distortion

  SITE REPORTED BILATERAL PATIENT INADVERTENTLY EXPOSED THE IMPLANTED LIGHT ADJUSTABLE LENSES TO AMBIENT UV LIGHT. BOTH OF THE LENSES WERE EXPLANTED. RXSIGHT'S AWARENESS DATE WAS 8/2/2021.

  Patient problems: Visual Disturbances

  MAUDE report 12368535 ↗
• InjuryAug 11, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12307582 ↗
• InjuryAug 9, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12294916 ↗
• InjuryJul 14, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 6/18/2021.

  Patient problems: Visual Impairment

  MAUDE report 12170720 ↗
• InjuryMay 28, 2021Optical Distortion; Optical Distortion

  THE SITE REPORTED THAT A PATIENT HAD BEEN IMPLANTED WITH A LIGHT ADJUSTABLE LENS, BUT DID NOT RETURN FOR ANY FOLLOW-UP LIGHT TREATMENTS. THE PATIENT ALSO DID NOT COMPLY WITH UV PROTECTIVE EYEWEAR. THE PATIENT RETURNED APPROXIMATELY 6 MONTHS AFTER CATARACT SURGERY WITH COMPLAINTS OF BLURRY VISION. PREMATURE PHOTOPOLYMERIZATION OF THE LENS WAS CONFIRMED. THE LENS WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 11902523 ↗
• InjuryMar 26, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED A DECREASE IN VISION IN THE RIGHT EYE. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 11576107 ↗
• InjuryMar 11, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 11467342 ↗
• InjuryDec 9, 2020Optical Distortion; Optical Distortion

  BILATERAL PATIENT REPORTED TO HAVE PREMATURE PHOTOPOLYMERIZATION OF THE LIGHT ADJUSTABLE LENS IMPLANTED IN PATIENT'S EYES. ONE EYE WAS EXPLANTED ON (B)(6) 2020 AND THE SECOND EYE WAS EXPLANTED ON (B)(6) 2020. RXSIGHT'S AWARENESS WAS 10/31/2020.

  Patient problems: Visual Disturbances

  MAUDE report 10980206 ↗
• InjuryOct 27, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT A BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S PERSISTENT COMPLAINTS OF LOWER VISUAL QUALITY. THE LENS WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT'S AWARE DATE OF THE EXPLANT WAS (B)(6) 2020).

  Patient problems: Visual Impairment

  MAUDE report 10744230 ↗
• InjuryJul 22, 2020Optical Distortion; Optical Distortion

  BILATERAL PATIENT IMPLANTED WITH THE LIGHT ADJUSTABLE LENS ((B)(6) 2020 FOR LEFT EYE; (B)(6) 2020 FOR RIGHT EYE). PATIENT WAS IN THE MIDDLE OF LIGHT TREATMENTS FOR BOTH EYES WHEN COVID-19 IMPACTED THE PATIENT AND PREVENTED THE PATIENT FROM VISITING THE CLINIC TO COMPLETE LIGHT TREATMENTS. UPON RETURN TO THE CLINIC 2 MONTHS LATER, PATIENT'S VISUAL ACUITY HAD DECREASED. THE PATIENT DID NOT MAINTAIN COMPLIANCE WITH UV SPECTACLE WEAR DURING THE PROLONGED INTERVAL CAUSED BY COVID-19 INTERRUPTION OF CLINICAL SERVICES. BOTH LENSES WERE EXPLANTED ON (B)(6) 2020 AND REPLACED WITH NEW LIGHT ADJUSTABLE LENSES.

  Patient problems: Visual Disturbances

  MAUDE report 10311256 ↗