RxSight Light Adjustable Lens (RxLAL) 60005-2170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020111), received between Sep 30, 2020 and Oct 4, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Optical Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2021Optical Problem; Optical Problem

  THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT DUE TO DYSPHOTOPSIA. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12573848 ↗
• InjuryJul 1, 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 12100674 ↗
• InjurySep 30, 2020Optical Problem; Optical Problem

  LIGHT ADJUSTABLE LENS WAS EXPLANTED ON (B)(6) 2020 FROM PATIENT'S RIGHT EYE AS DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS.

  Patient problems: Visual Impairment

  MAUDE report 10607400 ↗