RxSight Light Adjustable Lens (RxLAL) 60005-2140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020074), received between Aug 18, 2020 and Jan 27, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2022Optical 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 13368398 ↗
• InjuryAug 18, 2020Optical Distortion; Optical Distortion

  PATIENT WITH BILATERAL LIGHT ADJUSTABLE LENSES IMPLANTED. PATIENT REPORTED A DECREASE IN ACUITY 24-48 HOURS PRIOR TO LOCK-IN. PATIENT REPORTED AN INCIDENT WHERE UV SPECTACLES CAME OFF WHILE BOATING. SLIT LAMP REVEALED CENTRAL PREMATURE PHOTOPOLYMERIZATION OF THE LENSES. THE LENS IN THE RIGHT EYE WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT BECAME AWARE ON 7/21/2020) WHILE THE LEFT EYE WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT BECAME AWARE ON 7/28/2020).

  Patient problems: Visual Disturbances

  MAUDE report 10422424 ↗