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RxSight Light Adjustable Lens (RxLAL) 60005-2175Recalls & reported problems

Rxsight, Inc. · LAL, Sterile, Packaged, 17.5 Diopter · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818806020128), received between Jul 27, 2021 and Aug 23, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Optical Problem2

Patient problems

  • Visual Impairment2

Recent adverse event reports

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

  • InjuryAug 23, 2021Optical Problem; Optical Problem

    SITE REPORTED THE LAL WAS EXPLANTED FROM A PATIENT'S RIGHT EYE IN (B)(6) 2021. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2021.

    Patient problems: Visual Impairment

    MAUDE report 12355752 ↗
  • InjuryJul 27, 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. RXSIGH'TS FIRST AWARENESS OF THE EVENT WAS 06/30/2021.

    Patient problems: Visual Impairment

    MAUDE report 12232378 ↗

Other Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) devices

All Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.