RxSight Light Adjustable Lens (RxLAL) 60005-2235Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818806020241), received between Sep 2, 2022 and Sep 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Optical Distortion” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 LEFT EYE (OS) IS PLANNED TO BE EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15353188 ↗