RxSight Light Adjustable Lens (RxLAL) 60005-2190Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00818806020159), received between Oct 9, 2020 and Apr 10, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Optical Problem” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS ORIGINALLY IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +19.0D) ON (B)(6) 2019. THE PATIENT DID NOT RETURN TO THE CLINIC FOR ANY LIGHT TREATMENTS AFTER THE INITIAL IMPLANTATION. THE PATIENT PRESENTED SEVERAL YEARS LATER IN 2024. UPON CLINICAL EXAMINATION, FINDINGS CONSISTENT WITH PREMATURE PHOTOPOLYMERIZATION WERE NOTED. THE LAL WAS EXPLANTED AND REPLACED WITH ANOTHER LAL (SN (B)(6), +19.0D) ON (B)(6) 2024. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 03/12/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19081948 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +19.0D) WAS EXPLANTED ON (B)(6)2023 DUE TO PATIENT DISSATISFACTION. THE LAL WAS ORIGINALLY IMPLANTED ON (B)(6)2021. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17043766 ↗
• InjuryJun 16, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT DUE TO DYSPHOTOPSIA. 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 14717143 ↗
• InjuryJun 9, 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 5/13/2022.

  Patient problems: Visual Impairment

  MAUDE report 14643762 ↗
• InjuryFeb 23, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 13588190 ↗
• InjuryDec 20, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE PATIENT WAS EXPERIENCING DOUBLE VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 12/1/2021.

  Patient problems: Visual Impairment

  MAUDE report 13044242 ↗
• InjuryDec 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AS TO THE REASON FOR THE EXPLANT. RXSIGHT'S FIRST AWARENESS WAS 11/30/2021.

  Patient problems: Visual Impairment

  MAUDE report 12968836 ↗
• InjuryNov 23, 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 AWARENESS OF EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12860944 ↗
• InjuryNov 22, 2021Optical Problem; Optical Problem

  SITE REPORTED THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12858201 ↗
• InjurySep 10, 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 (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12455488 ↗
• InjuryJul 12, 2021Optical Distortion; Optical Distortion

  THE SITE REPORTED THAT A BILATERAL PATIENT HAD BEEN IMPLANTED WITH A LIGHT ADJUSTABLE LENS, BUT DID NOT RETURN FOR ANY FOLLOW-UP LIGHT ADJUSTMENT TREATMENTS. THE PATIENT ALSO DID NOT COMPLY WITH UV PROTECTIVE EYEWEAR. THE PATIENT RETURNED APPROXIMATELY 6 MONTHS AFTER CATARACT SURGERY WITH COMPLAINTS OF BLURRY VISION. PREMATURE PHOTOPOLYMERIZATION OF THE LENS WAS CONFIRMED. THE LENS IN THE RIGHT EYE WAS EXPLANTED ON (B)(6) 2021. THE LENS WITHIN THE LEFT EYE WAS EXPLANTED ON (B)(6) 2021 AND WAS REPORTED UNDER 3012712027-2021-00022.

  Patient problems: Visual Disturbances

  MAUDE report 12155296 ↗
• InjuryMay 6, 2021Optical Distortion; Optical Distortion

  SITE REPORTED THAT PATIENT WAS INITIALLY IMPLANTED WITH THE LIGHT ADJUSTABLE LENS AND HAD A GOOD OUTCOME. THE PATIENT THEN REPORTED CLOUDY VISION. RETROILLUMINATION OF THE EYE VERIFIED PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 11784987 ↗
• InjuryNov 24, 2020Scratched Material; Scratched Material

  SURGEON REPORTED THAT LENS IMPLANTED IN PATIENT'S RIGHT EYE HAD SCRATCHES VISIBLE ON THE POSTERIOR SURFACE OF THE LENS. THE LENS WAS EXPLANTED (RXSIGHT'S FIRST AWARENESS WAS 10/27/2020).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899215 ↗
• InjuryOct 16, 2020Optical Distortion; Optical Distortion

  PATIENT PRESENTED FOR LIGHT ADJUSTMENT WITH A MARKED CHANGE IN VISUAL ACUITY (PREVIOUSLY BCVA WAS 20/15, AFTER REPORTED CHANGE 20/30) IN THE RIGHT EYE. THE SURGEON, SUSPECTING PREMATURE PHOTOPOLYMERIZATION OF THE LENS, EXPLANTED THE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 10693537 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WITH PRIOR HISTORY OF YAG CAPSULOTOMY HAD PREVIOUS NON-RX SIGHT, SINGLE-PIECE ACRYLIC LENS REMOVED ON (B)(6) 2020 IN LEFT EYE. THE HAPTICS OF THE SINGLE-PIECE ACRYLIC LENS WERE LEFT WITHIN THE CAPSULAR BAG AND THE LIGHT ADJUSTABLE LENS WAS IMPLANTED DURING THE EXCHANGE, HOWEVER THE STABILITY OF THE BAG COULD NOT BE VERIFIED. LIGHT ADJUSTABLE LENS WAS NOTED TO BE DISLOCATED ON (B)(6) 2020. PATIENT WAS REFERRED TO A RETINAL SPECIALIST WHO PERFORMED SCLERAL FIXATION OF THE LIGHT ADJUSTABLE LENS TO RESOLVE THE ISSUE. FOLLOWING PROCEDURE, PATIENT'S EYE IS STABLE, AND PATIENT IS HAPPY WITH 20/20 VISION.

  Patient problems: Blurred Vision

  MAUDE report 10659660 ↗