RxSight Light Adjustable Lens (RxLAL) 60005-2165Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806020104), received between Aug 21, 2020 and Oct 28, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 10/01/2021.

  Patient problems: Visual Impairment

  MAUDE report 12711974 ↗
• InjuryOct 25, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED NON-COMPLIANCE WITH UV SPECTACLE WEAR. SUSPECTED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE ON (B)(6) 2021. RXSIGHT'S AWARENESS DATE WAS 9/29/2021.

  Patient problems: Visual Disturbances

  MAUDE report 12693851 ↗
• InjuryOct 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 9/2/2021.

  Patient problems: Visual Impairment

  MAUDE report 12565662 ↗
• InjuryJun 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DOCTOR NOTED AFTER SEVERAL LDD TREATMENTS THAT THE LIGHT ADJUSTABLE LENS WAS IMPLANTED BACKWARDS INTO THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12064184 ↗
• InjuryAug 21, 2020Optical Distortion; Optical Distortion

  PATIENT IMPLANTED WITH LIGHT ADJUSTABLE LENS ON (B)(6) 2020. SITE REPORTED THAT PATIENT HAD PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2020 AND ANOTHER LAL WAS IMPLANTED. RX SIGHT'S FIRST AWARENESS OF THE EVENT WAS 7/23/2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 10438658 ↗