RxSight Light Adjustable Lens (RxLAL) 60005-2185Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818806020142), received between Sep 11, 2020 and Mar 11, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Optical Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT'S LEFT 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 13733983 ↗
• InjuryAug 31, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED DUE TO VISUAL DISTURBANCES. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12394391 ↗
• InjuryAug 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 7/15/2021.

  Patient problems: Visual Impairment

  MAUDE report 12302294 ↗
• InjuryFeb 9, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 11305419 ↗
• InjuryOct 9, 2020Optical Distortion; Optical Distortion

  PATIENT REPORTED TO HAVE SPENT TIME INDOORS BY WINDOWS WITHOUT UV PROTECTIVE EYEWEAR RESULTING IN DECREASED VISUAL ACUITY IN THE LEFT EYE. PREMATURE PHOTOPOLYMERIZATION CONFIRMED, RESULTING IN EXPLANT OF THE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 10659106 ↗
• InjurySep 11, 2020Optical Distortion; Optical Distortion

  TWO DAYS FOLLOWING LIGHT TREATMENT, PATIENT NOTED A DECREASE IN ACUITY AND QUALITY OF VISION. EXAMINATION CONFIRMED A DECREASE IN BCVA. RETROILLUMINATION NOTED A DEFECT NEAR THE CENTER OF THE LENS CONSISTENT WITH PREMATURE PHOTOPOLYMERIZATION OF THE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 10522405 ↗