RxSight Light Adjustable Lens (RxLAL) 60005-2250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818806020265), received between Aug 13, 2020 and Dec 16, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Optical Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PHYSICIAN REPORTED THAT AS LENS WAS DELIVERED INTO THE EYE, THE LEADING HAPTIC CAUGHT THE ANTERIOR RHEXIS, RESULTING IN A SMALL TEAR OF THE ANTERIOR CAPSULE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11016893 ↗
• InjuryDec 9, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT PATIENT WITH HISTORY OF RADIAL KERATOTOMY (RK) HAD THE LIGHT ADJUSTABLE LENS EXPLANTED FROM THE RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. THE LENS WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Visual Impairment

  MAUDE report 10980132 ↗
• InjuryOct 27, 2020Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS.

  Patient problems: Visual Impairment

  MAUDE report 10744233 ↗
• InjuryAug 13, 2020Optical Problem; Optical Problem

  BILATERAL PATIENT PREVIOUSLY HAD RIGHT EYE EXPLANTED ON (B)(6) 2020. LENS WITHIN THE LEFT EYE WAS EXPLANTED DUE TO A VISUAL ACUITY ISSUE ON (B)(6) 2020 (RXSIGHT'S AWARE DATE WAS (B)(6) 2020).

  Patient problems: Visual Impairment

  MAUDE report 10402350 ↗