RxSight Light Adjustable Lens (RxLAL) 60005-2200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818806020173), received between May 1, 2019 and Feb 24, 2022 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 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 THIS EVENT WAS (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 13591520 ↗
• InjuryNov 16, 2021Optical Problem; Optical Problem

  THE SITE REPORTED AN LAL WAS PIGGYBACKED WITH A STANDARD IMPLANT AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12820165 ↗
• InjuryNov 11, 2021Optical Problem; Optical Problem

  SITE REPORTED A BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED DUE TO PHOTOPSIA. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 12800326 ↗
• InjuryOct 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SIGHT 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 9/16/2021.

  Patient problems: Visual Impairment

  MAUDE report 12628129 ↗
• InjuryApr 28, 2021Unintended Movement; Unintended Movement

  PHYSICIAN REPORTED DURING DELIVERY OF THE LAL, THE SURGEON FELT THE LENS EXITED THE CARTRIDGE QUICKLY, CAUSING A TEAR IN THE BAG AT THE EQUATOR. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ADDITIONAL ISSUE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11739588 ↗
• InjuryMar 25, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S LEFT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS.

  Patient problems: Visual Impairment

  MAUDE report 11571130 ↗
• InjuryMar 12, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED EXPERIENCING HALOS, GLARE, AND BLURRY VISION. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED ON (B)(6)2021 FROM THE LEFT EYE. RXSIGHT'S FIRST AWARENESS OF THE ISSUE WAS 2/16/2021.

  Patient problems: Visual Disturbances

  MAUDE report 11478319 ↗
• InjuryFeb 26, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 1/29/2021.

  Patient problems: Visual Impairment

  MAUDE report 11387562 ↗
• InjuryDec 12, 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 AFTER LIGHT ADJUSTMENT TREATMENTS. THE LENS WAS EXPLANTED ON (B)(6) 2020. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 11/13/2020.

  Patient problems: Visual Impairment

  MAUDE report 10994446 ↗
• InjurySep 30, 2020Optical Problem; Optical Problem

  LIGHT ADJUSTABLE LENS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT'S PERSISTENT COMPLAINTS OF LOWER VISUAL QUALITY, ALTHOUGH UNCORRECTED VISUAL ACUITY WAS 20/20. PATIENT HAD HISTORY OF LASIK IN THE RIGHT EYE. THE LENS WAS REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS.

  Patient problems: Visual Impairment

  MAUDE report 10607439 ↗
• InjuryJun 17, 2020Optical Distortion; Optical Distortion

  PATIENT WITH BILATERAL LIGHT ADJUSTABLE LENS IMPLANTS ON (B)(6) 2020 WITHOUT ISSUE. PATIENT REPORTED BLURRED VISION ON (B)(6) 2020. PREMATURE PHOTOPOLYMERIZATION DETECTED. PATIENT REPORTED 75% COMPLIANCE WITH WEARING UV PROTECTIVE EYEWEAR (TREATMENTS WERE DELAYED DUE TO COVID-19). BOTH LENSES WERE EXPLANTED: RIGHT EYE EXPLANTED ON (B)(6) 2020 (RXSIGHT'S FIRST AWARENESS WAS 5/20/2020). LEFT EYE WAS EXPLANTED ON (B)(6) 2020. BOTH LENSES ARE PENDING RETURN FOR EVALUATION.

  Patient problems: Visual Disturbances

  MAUDE report 10164837 ↗
• InjuryNov 22, 2019Optical Distortion; Optical Distortion

  PATIENT REPORTED TO HAVE UNEVENTFUL IMPLANTATION OF THE LIGHT ADJUSTABLE LENS ON (B)(6) 2019. LENS ADJUSTMENTS OCCURED WITHOUT ISSUE. LOCK-IN TREATMENT WAS PERFORMED WITH THE PATIENT'S IRIS NOT FULLY DILATED. THIS RESULTED IN AN INCOMPLETE LOCK-IN OF THE LENS. AFTER COMPLETION OF THE LOCK-IN PROCEDURE, THE PATIENT STOPPED WEARING THE UV PROTECTIVE EYEWEAR, CAUSING THE LENS TO CONTINUE TO POLYMERIZE. THE POLYMERIZATION RESULTED IN POOR VISUAL ACUITY AND VISUAL DISTURBANCES (MONOCULAR GLARE AND STARBURST) IN THE RIGHT EYE ONLY. THE LENS WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 9363291 ↗
• InjuryMay 1, 2019Optical Distortion; Optical Distortion

  PATIENT REPORTED TO HAVE UNEVENTFUL IMPLANTATION OF THE LIGHT ADJUSTABLE LENS ON (B)(6) 2018. LENS ADJUSTMENT AND LOCK-IN LIGHT TREATMENTS WERE PERFORMED WITH THE PATIENT'S IRIS NOT FULLY DILATED. THIS RESULTED IN AN INCOMPLETE ADJUSTMENT AND LOCK-IN OF THE LENS. AFTER COMPLETION OF THE LOCK-IN PROCEDURE, THE PATIENT STOPPED WEARING THE UV PROTECTIVE EYEWEAR, CAUSING THE LENS TO CONTINUE TO POLYMERIZE. THE POLYMERIZATION RESULTED IN POOR VISUAL ACUITY AND VISUAL DISTURBANCES (GHOSTING). THE LENS WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 8570808 ↗