RxSight Light Adjustable Lens (RxLAL) 60005-2205Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00818806020180), received between Sep 25, 2020 and May 5, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Optical Problem” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2022Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT DUE TO MONOCULAR DIPLOPIA. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS 4/5/2022.

  Patient problems: Visual Impairment

  MAUDE report 14287087 ↗
• InjuryMar 30, 2022Optical Problem; Optical Problem

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

  Patient problems: Visual Impairment

  MAUDE report 13956801 ↗
• InjuryOct 11, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED A CHANGE IN VISUAL ACUITY SEVERAL DAYS AFTER THE FIRST LOCKIN. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED. RXSIGHT'S FIRST AWARENESS WAS (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12606280 ↗
• InjuryJul 28, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 7/2/2021.

  Patient problems: Visual Impairment

  MAUDE report 12243123 ↗
• InjuryJul 6, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 6/18/2021.

  Patient problems: Visual Impairment

  MAUDE report 12123580 ↗
• InjuryApr 9, 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. ANOTHER LIGHT ADJUSTABLE LENS WAS IMPLANTED IN THE EXCHANGE.

  Patient problems: Visual Impairment

  MAUDE report 11645181 ↗
• InjuryMar 18, 2021Optical Problem; Optical Problem

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

  Patient problems: Visual Impairment

  MAUDE report 11518111 ↗
• InjuryMar 18, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED EXPERIENCING DYSPHOTOPSIA AND ANISOMETROPIA. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE ON (B)(6) 2021. IT IS UNKNOWN WHEN THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S LEFT EYE WAS EXPLANTED, ALTHOUGH THE EXPLANTED LENS WAS RECEIVED ON (B)(6) 2021.

  Patient problems: Visual Disturbances

  MAUDE report 11517788 ↗
• InjurySep 25, 2020Optical Distortion; Optical Distortion

  BILATERAL PATIENT REPORTED ISSUES WITH HALOS AND GLARE. THE PATIENT REPORTED SPENDING TIME OUTDOORS WITHOUT WEARING UV PROTECTIVE WEAR. BOTH LENSES WERE EXPLANTED (LEFT EYE ON (B)(6) 2020, RIGHT EYE ON (B)(6) 2020). RXSIGHT'S FIRST AWARENESS DATE WAS (B)(6) 2020.

  Patient problems: Visual Disturbances

  MAUDE report 10590446 ↗