RxSight Light Adjustable Lens (RxLAL) 60005-3060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020913), received between Jun 1, 2023 and Jun 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Optical Decentration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +6.0D) WAS EXPLANTED FROM THE EYE DUE TO LENS DECENTRATION SECONDARY TO POSSIBLE ZONULAR DEHISCENCE OR A KINKED HAPTIC DURING DELIVERY OF THE LAL WHICH WAS CAUSED BY PRIOR INCOMPLETE REMOVAL OF AN IMPLANTABLE COLLAMER LENS; A NEW LAL (SN (B)(6), +6.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22137773 ↗
• InjuryApr 25, 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 LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +6.0D) THAT WAS INITIALLY PLACED AS A PIGGYBACK INTRAOCULAR LENS IN THE CAPSULAR BAG WAS EXPLANTED FROM THE RIGHT EYE DUE TO BLURRY VISION AND A NEW LAL (SN (B)(6), +8.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21910600 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6)) WAS EXPLANTED ON (B)(6) 2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17043647 ↗