RxSight Light Adjustable Lens (RxLAL) 60005-3110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020555), received between Oct 29, 2024 and Apr 29, 2026 — 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.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRED VISION AFTER TARGETING MYOPIA AND A NEW LAL IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25032503 ↗
• InjuryDec 9, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +11.0D) INTO THE SULCUS DUE TO LENS DECENTRATION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20880841 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT WAS DISSATISFIED WITH THE DISTANCE VISION IN THEIR RIGHT EYE AFTER COMPLETION OF LIGHT TREATMENTS DUE TO THE CHOSEN REFRACTIVE TARGET. THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +11.0D) WAS EXPLANTED AND AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. AFTER THE IOL EXCHANGE, THE PATIENT REPORTED VISION WAS STILL BLURRY WITH UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/50, UNCORRECTED NEAR VISUAL ACUITY (UCNVA) J5, MANIFEST REFRACTION (MR) -1.00 SPHERE, AND BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20.

  Patient problems: Blurred Vision

  MAUDE report 20559422 ↗