RxSight Light Adjustable Lens (RxLAL) 60005-2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020036), received between Feb 11, 2021 and Nov 23, 2022 — classified as 2 injuries.

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

• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 10/24/2022.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15857721 ↗
• InjuryFeb 11, 2021Optical Problem; Optical Problem

  SITE REPORTED, 10 DIOPTER LENS WAS IMPLANTED INTO THE LEFT EYE. AND THE PATIENT WAS +4.00 POSTOPERATIVELY. AND REMAINED HYPEROPIC FOLLOWING LIGHT TREATMENTS. THE LENS WAS EXPLANTED. AND A 15 DIOPTER LAL WAS IMPLANTED ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 11319754 ↗