RxSight Light Adjustable Lens (RxLAL) 60005-2270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818806020289), received between Jul 13, 2020 and Dec 1, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Optical Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2021Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT DUE TO DYSPHOTOPSIA. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS WAS 11/9/2021.

  Patient problems: Visual Impairment

  MAUDE report 12908984 ↗
• InjuryNov 25, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT PATIENT WITH HISTORY OF RADIAL KERATOTOMY (RK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) HAD THE LIGHT ADJUSTABLE LENS EXPLANTED FROM THE LEFT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. THE LENS WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT'S FIRST AWARENESS WAS 10/29/2020).

  Patient problems: Visual Impairment

  MAUDE report 10907250 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED FOR LDD TREATMENT WITH IRITIS. THE DOCTOR ALSO NOTED IRIS ADHESION, PREVENTING COMPLETE DILATION. THE PHYSICIAN SURGICALLY BROKE THE IRIS ADHESION TO RESOLVE THE ISSUE.

  Patient problems: Iritis

  MAUDE report 10857310 ↗
• InjuryJul 13, 2020Optical Distortion; Optical Distortion

  PATIENT WITH BILATERAL LIGHT ADJUSTABLE LENS IMPLANTS (LEFT EYE ON (B)(6) 2020; RIGHT EYE ON (B)(6) 2020). PATIENT REPORTED VISUAL DISTURBANCES AND DECREASE IN VISION PRIOR TO ADJUSTMENT PROCEDURE ON (B)(6) 2020. THE DELAY IN STARTING LIGHT TREATMENTS WERE DUE TO COVID-19. DIAGNOSTIC TESTING CONFIRMED DECREASE IN VISUAL ACUITY WITH THE DECREASE IN THE LEFT EYE GREATER (BCDVA 20/60) THAN THE RIGHT EYE (BCDVA 20/32). DIAGNOSTIC TESTING ALSO CONFIRMED BILATERAL PREMATURE PHOTOPOLYMERIZATION. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH UV PROTECTIVE WEAR. SURGEON ELECTED TO PROCEED WITH LIGHT TREATMENTS ON THE RIGHT EYE AND TO EXPLANT THE LENS IN THE LEFT EYE. LENS (27.0 DIOPTER) IN LEFT EYE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A TORIC LENS (27.5 DIOPTER).

  Patient problems: Visual Disturbances

  MAUDE report 10268565 ↗