RxSight Light Adjustable Lens (RxLAL) 60005-3090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818806020944), received between May 9, 2024 and Apr 11, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2026Optical Decentration

  A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +9.0D) WAS IMPLANTED ON (B)(6) 2025 DURING PRIMARY CATARACT SURGERY IN THE RIGHT EYE. POSTOPERATIVELY, ON (B)(6) 2025, A RETINAL TEAR WITH DETACHMENT WAS DIAGNOSED IN THE RIGHT EYE. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO REPAIR THE RETINAL DETACHMENT. AT THE PATIENT'S POSTOPERATIVE EXAM, ON (B)(6) 2025, THE PATIENT REPORTED INVOLVEMENT IN A CAR ACCIDENT ON (B)(6) 2025. ON (B)(6) 2025, MACULAR EDEMA AND EPIRETINAL MEMBRANE WERE DIAGNOSED IN THE RIGHT EYE AND THE LAL WAS NOTED DECENTERED. ON (B)(6) 2025, THE PATIENT UNDERWENT A SECONDARY SURGICAL PROCEDURE CONSISTING OF A PARS PLANA VITRECTOMY, EPIRETINAL/INTERNAL LIMITING MEMBRANE PEEL, AND LENS REPOSITIONING. ON (B)(6) 2025, THE PATIENT COMPLAINED OF DYSPHOTOPSIA IN THE RIGHT EYE. ON (B)(6) 2025, AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE LENS IN THE EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24849396 ↗
• InjuryJun 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, (B)(6), +9.0D) WAS IMPLANTED ON (B)(6) 2024. THE PATIENT COMPLETED ONE ADJUSTMENT TREATMENT ON (B)(6) 2025 AND NO LOCK IN TREATMENTS BEFORE EXPOSURE TO UV LIGHT FROM A TANNING BED. THE PATIENT REPORTED PERSISTENT BLURRY VISION AFTER THE EXPOSURE. THE LAL WAS EXPLANTED ON (B)(6) 2025 AND A REPLACEMENT LAL (B)(6), +19.0D) WAS SUBSEQUENTLY IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 22342610 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +9.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES. AN IOL FROM ANOTHER MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. ONE WEEK AFTER THE IOL EXCHANGE, THE PATIENT CONTINUED TO REPORT VISUAL DISTURBANCES WITH THE NEW IOL.

  Patient problems: Visual Disturbances

  MAUDE report 21980104 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +9.0D) IMPLANTED ON (B)(6) 2022. ON (B)(6) 2024, 15 MONTHS AFTER THE ORIGINAL IMPLANTATION, THE LAL WAS EXPLANTED DUE TO THE DEVELOPMENT OF DEPOSITS THAT AFFECTED THE PATIENT'S VISION. AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 04/09/2024.

  Patient problems: Visual Impairment

  MAUDE report 19282710 ↗