RxSight Light Adjustable Lens (RxLAL) 60005-3300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818806020814), received between Sep 5, 2024 and Jun 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 6, 2025Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +30.0D) WAS IMPLANTED ON (B)(6) 2024. AFTER TWO LIGHT TREATMENTS, THE TREATING PHYSICIAN OBSERVED THE LENS TO BE DISLOCATED. THE LAL WAS EXPLANTED ON (B)(6) 2025, AND ANOTHER LAL (SN (B)(6), +30.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22160226 ↗
• MalfunctionSep 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +30.0D) WAS IMPLANTED BACKWARDS IN THE LEFT EYE DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON DECIDED TO EXCHANGE THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/21/2024. REFERENCE REPORT # 3012712027-2024-00170 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251631 ↗
• InjurySep 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +30.0D) WAS EXPLANTED DUE TO THE INCORRECT DIOPTER POWER CALCULATED FOR THE PATIENT AND A NEW LAL (SN (B)(6), +17.0D) IMPLANTED AS A REPLACEMENT. THE SITE ATTRIBUTED THE INITIAL INCORRECT DIOPTER POWER CALCULATION TO THE PATIENT'S RETINAL DETACHMENT, WHICH OCCURRED IN THE MONTHS PRIOR TO THE IOL IMPLANT SURGERY. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/07/2024.

  Patient problems: Visual Impairment

  MAUDE report 20152858 ↗