RxSight Light Adjustable Lens (RxLAL) 60005-2210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818806020197), received between Oct 9, 2020 and Nov 9, 2021 — 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.

• InjuryNov 9, 2021Optical Problem; Optical Problem

  SITE REPORTED 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 12782948 ↗
• InjurySep 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/23/2021.

  Patient problems: Visual Impairment

  MAUDE report 12501138 ↗
• InjuryAug 5, 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 12281372 ↗
• InjuryJul 27, 2021Optical Problem; Optical Problem

  SITE REPORTED BILATERAL PATIENT UNDERWENT LAL IMPLANTATION IN (B)(6) 2021 ((B)(6)2021 FOR THE LEFT EYE AND (B)(6) 2021 FOR THE RIGHT EYE). THE LALS WERE EXPLANTED IN (B)(6) 2021 (6/28/2021 FOR THE RIGHT EYE, (B)(6) 2021 FOR THE LEFT EYE). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON 7/1/2021.

  Patient problems: Visual Impairment

  MAUDE report 12234771 ↗
• InjuryJul 10, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE PATIENT WAS EXPERIENCING DOUBLE VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 6/18/2021.

  Patient problems: Visual Impairment

  MAUDE report 12148144 ↗
• InjuryOct 9, 2020Misfocusing; Misfocusing

  PATIENT IMPLANTED WITH LIGHT ADJUSTABLE LENS IN RIGHT EYE. FOLLOWING LIGHT TREATMENTS AND LOCK-IN, THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED. THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER LIGHT ADJUSTABLE LENS. RXSIGHT'S FIRST AWARENESS OF THE LENS EXPLANT WAS (B)(6) 2020.

  Patient problems: Blurred Vision

  MAUDE report 10659107 ↗