RxSight Light Adjustable Lens (RxLAL) 60005-3120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806020562), received between Oct 21, 2022 and Sep 25, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjurySep 25, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +12.0D) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT DISSATISFACTION WITH THE REFRACTIVE TARGET CHOSEN BY THE TREATING PHYSICIAN. A NEW LAL (SN (B)(6), +10.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/28/2024.

  Patient problems: Visual Impairment

  MAUDE report 20306833 ↗
• InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT ON (B)(6) 2023, A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +12.0D) WAS IMPLANTED IN A PATIENT'S SULCUS. DURING THE ONE-DAY POSTOPERATIVE EXAM (B)(6) 2023), THE LAL WAS NOTED TO BE DISPLACED IN THE POSTERIOR CHAMBER. ON (B)(6) 2024, A PARS PLANA VITRECTOMY WAS COMPLETED, AND THE LENS WAS REPOSITIONED VIA SUTURELESS INTRASCLERAL FIXATION (SIS). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/11/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19956299 ↗
• InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +12.0D) WAS OBSERVED TO BE DISLOCATED AFTER PRIMARY CATARACT SURGERY. AN ADDITIONAL PROCEDURE WAS CONDUCTED WHERE THE SURGEON ATTEMPTED TO RE-POSITION THE LAL. DURING THE REPOSITIONING PROCEDURE, IT WAS NOTED THAT THE LENS HAPTICS WERE DISTORTED. THE LAL WAS EXPLANTED AND AN ANTERIOR CHAMBER INTRAOCULAR LENS WAS IMPLANTED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 06/20/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19767029 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +12.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION. AN IOL OF A DIFFERENT BRAND WAS IMPLANTED AS REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 11/21/2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18352443 ↗
• InjuryOct 21, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) HAS BEEN EXPLANTED DUE TO THE PATIENT HAVING A MORE MYOPIC THAN DESIRED OUTCOME. THE LENS WAS EXPLANTED ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15655726 ↗