RxSight Light Adjustable Lens (RxLAL) 60005-2150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020081), received between Dec 20, 2021 and Jun 19, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Optical Problem” (2 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.

• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S PRE-ACTIVSHIELD LIGHT ADJUSTABLE LENS ((B)(6)) WAS EXPLANTED 4 YEARS AFTER IMPLANTATION DUE TO VISUAL DISTURBANCES. CENTRAL HAZE WAS OBSERVED ON THE LENS PRIOR TO EXPLANT.

  Patient problems: Visual Disturbances

  MAUDE report 22294454 ↗
• InjuryMar 11, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 13741388 ↗
• InjuryDec 20, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 12/1/2021.

  Patient problems: Visual Impairment

  MAUDE report 13047908 ↗