RxSight Light Adjustable Lens (RxLAL) 60005-2130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020067), received between Sep 3, 2021 and Mar 29, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Optical Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2022Optical Problem; Optical Problem

  SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. ANOTHER LAL WAS IMPLANTED IN THE RIGHT EYE DURING THE EXCHANGE ON (B)(6) 2022 AND ANOTHER LAL WAS IMPLANTED IN THE LEFT EYE 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 13938479 ↗
• InjurySep 3, 2021Optical Problem; Optical Problem

  SITE REPORTED BILATERAL PATIENT HAD THE LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. BOTH OF THE LENSES WERE EXPLANTED (RIGHT EYE EXPLANTED (B)(6) 2021; LEFT EYE EXPLANTED (B)(6) 2021). RXSIGHT'S AWARENESS DATE WAS 8/10/2021.

  Patient problems: Visual Impairment

  MAUDE report 12426051 ↗