RxSight Light Adjustable Lens (RxLAL) 60005-3280Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818806020791), received between Feb 4, 2023 and Feb 4, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED DURING AN IMPLANT SURGERY FOR A LIGHT ADJUSTABLE LENS (LAL, SN (B)(4), 28.0D), IT WAS NOTED THAT THE POSTERIOR CAPSULE WAS TORN. BECAUSE OF PREVIOUS RADIAL KERATOTOMY (RK), EXTENDING INCISION TO REMOVE THE LENS WAS NOT FEASIBLE, SO THE SURGEON CUT THE LENS IN HALF AND ATTEMPTED TO REMOVE IT. ONE HALF OF THE LENS WAS SUCCESSFULLY REMOVED, BUT THE OTHER HALF OF THE LENS FELL INTO THE VITREOUS. THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST FOR REMOVAL. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Capsular Bag Tear

  MAUDE report 16301371 ↗