RxSight Light Adjustable Lens (RxLAL) 60005-2180Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818806020135), received between Sep 10, 2019 and Dec 6, 2022 — classified as 13 injuries.

The most frequently reported specific device problem is “Optical Problem” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION AND SUSPECTED ZONE FORMATION. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15928468 ↗
• InjurySep 2, 2022Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15353006 ↗
• InjuryJul 7, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED DUE TO ZONE FORMATION FROM AMBIENT UV LIGHT EXPOSURE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 14941484 ↗
• InjuryMay 11, 2022Optical Problem; Optical Problem

  SITE REPORTED A PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED ON (B)(6) 2022. RXSIGHT'S AWARENESS OF THE EVENT WAS 4/13/2022.

  Patient problems: Visual Impairment

  MAUDE report 14364063 ↗
• InjuryApr 12, 2022Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 3/15/2022.

  Patient problems: Visual Impairment

  MAUDE report 14091394 ↗
• InjurySep 27, 2021Optical Distortion; Optical Distortion

  SITE REPORTED THAT A PATIENT WAS HAVING THE LIGHT ADJUSTABLE LENS EXPLANTED FROM THE LEFT EYE BECAUSE THE PATIENT WAS NOT FULLY COMPLIANT TO UV SPECTACLE WEAR. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 8/30/2021.

  Patient problems: Visual Disturbances

  MAUDE report 12533861 ↗
• InjuryAug 5, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 7/15/2021.

  Patient problems: Visual Impairment

  MAUDE report 12281572 ↗
• InjuryJul 29, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S LEFT EYE WAS EXPLANTED AS THE PATIENT WAS UNHAPPY WITH HER VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 7/6/2021.

  Patient problems: Visual Impairment

  MAUDE report 12246979 ↗
• InjuryJan 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHYSICIAN REPORTED THAT AS LENS WAS DELIVERED INTO THE EYE, THE PHYSICIAN DID NOT PROPERLY GUIDE THE LEADING HAPTIC INTO THE CAPSULAR BAG, CAUSING A RUPTURE OF THE CAPSULAR BAG. PHYSICIAN PERFORMED A VITRECTOMY AND NOTED THE LENS REMAINS SECURELY PLACED IN THE BAG.

  Patient problems: Capsular Bag Tear

  MAUDE report 11211006 ↗
• InjuryDec 29, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENS EXPLANTED FROM THE RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED. THE LENS WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS OF THE SAME DIOPTER.

  Patient problems: Visual Impairment

  MAUDE report 11088460 ↗
• InjuryDec 21, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 11/30/2020.

  Patient problems: Visual Impairment

  MAUDE report 11051035 ↗
• InjuryOct 23, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2020.

  Patient problems: Visual Impairment

  MAUDE report 10731315 ↗
• InjurySep 10, 2019Optical Problem; Optical Problem

  FOLLOWING SUCCESSFUL CATARACT SURGERY AND IMPLANTATION OF THE LIGHT ADJUSTABLE LENS ON (B)(6) 2019, THE PATIENT DID NOT WEAR UV SPECTACLES. AS A RESULT, A CENTRAL POLYMERIZATION ZONE WAS NOTED ON THE LIGHT ADJUSTABLE LENS DURING THE EXAM. THE LENS WAS EXPLANTED ON (B)(6) 2019 AND A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 8984166 ↗