RxSight Light Adjustable Lens (RxLAL) 60005-3290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020807), received between Dec 7, 2021 and Apr 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryApr 3, 2026Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +29.0D) WAS EXPLANTED FROM THE LEFT EYE PRIOR TO ANY LIGHT TREATMENTS DUE TO A REFRACTIVE SURPRISE. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. IT WAS REPORTED THAT THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Blurred Vision

  MAUDE report 24778075 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED A CAPSULE TEAR DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS. THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 11/30/2021.

  Patient problems: Capsular Bag Tear

  MAUDE report 12953240 ↗