RxSight Light Adjustable Lens (RxLAL) 60005-2160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020098), received between Aug 12, 2020 and Mar 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Optical Distortion” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT PATIENT WITH LIGHT ADJUSTABLE LENS IMPLANTED IN THE SULCUS HAD THE LENS EXPLANTED ON (B)(6) 2021 FROM THE RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS.

  Patient problems: Visual Impairment

  MAUDE report 11518222 ↗
• InjuryAug 12, 2020Optical Distortion; Optical Distortion

  PATIENT IMPLANTED WITH LIGHT ADJUSTABLE LENS ((B)(6) 2020) IN THE RIGHT EYE ADMITTED TO POOR COMPLIANCE WITH UV SPECTACLES IMMEDIATELY AFTER SURGERY. PATIENT DEVELOPED A LOSS OF VISUAL ACUITY. THE LIGHT ADJUSTABLE LENS WAS EXPLANTED (SERIAL NUMBER OF EXPLANTED LENS: (B)(6)) AND EXCHANGED WITH ANOTHER LIGHT ADJUSTABLE LENS (SERIAL NUMBER OF IMPLANTED LENS: (B)(6)) OF THE SAME DIOPTER POWER ON (B)(6) 2020. PATIENT AGAIN DID NOT COMPLY WITH UV SPECTACLE WEAR AND DEVELOPED A LOSS OF VISUAL ACUITY. THE LENS WAS EXPLANTED ON (B)(6) 2020 AND EXCHANGED WITH A 3-PIECE MONOFOCAL IOL. RXSIGHT'S FIRST AWARENESS OF THE EXPLANT ON (B)(6) 2020 INVOLVING SERIAL NUMBER (B)(6) WAS (B)(6) 2020. RXSIGHT'S FIRST AWARENESS OF THE EXPLANT ON (B)(6) 2020 INVOLVING SERIAL NUMBER (B)(6) WAS (B)(6) 2020.

  Patient problems: Visual Disturbances

  MAUDE report 10397103 ↗