RxSight Light Adjustable Lens (RxLAL) 60005-3100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020548), received between May 11, 2023 and Jun 1, 2023 — 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.

• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT DURING AN IMPLANT PROCEDURE FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 10.0D) A CAPSULAR BAG TEAR OCCURRED. THE SURGEON PERFORMED A VITRECTOMY AND PLACED THE LAL INTO THE POSTERIOR CHAMBER. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 17044204 ↗
• InjuryMay 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4) +10.0D) WAS EXPLANTED DUE TO THE PATIENT HAVING AN UNEXPECTED HYPEROPIC OUTCOME POST OP. THE INITIAL LAL WAS EXPLANTED ON (B)(6) 2023, AND WAS REPLACED WITH ANOTHER LAL (SN (B)(4) +17.0D). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 16915909 ↗