RxSight Light Adjustable Lens (RxLAL) 60005-2240Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818806020258), received between Oct 8, 2020 and Dec 20, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT A LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT AS THE PATIENT WAS EXPERIENCING DOUBLE VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 12/1/2021.

  Patient problems: Visual Impairment

  MAUDE report 13049052 ↗
• InjuryAug 6, 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 12291901 ↗
• InjuryJul 9, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME FOR NEAR VISION WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2021.

  Patient problems: Visual Impairment

  MAUDE report 12147454 ↗
• InjuryOct 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PHYSICIAN REPORTED A PATIENT UNDERGOING FEMTOSECOND LASER-ASSISTED CATARACT SURGERY HAD A CAPSULE TEAR DURING CATARACT SURGERY.

  Patient problems: Capsular Bag Tear

  MAUDE report 10685519 ↗
• InjuryOct 8, 2020Optical Distortion; Optical Distortion

  BILATERAL PATIENT REPORTED TO HAVE SPENT TIME OUTDOORS WITHOUT UV PROTECTIVE EYEWEAR RESULTING IN DECREASED VISUAL ACUITY DUE TO PREMATURE PHOTOPOLYMERIZATION OF BOTH LENSES. RIGHT EYE (IMPLANTED (B)(6) 2020) WAS EXPLANTED ON (B)(6) 2020. LEFT EYE (IMPLANTED (B)(6)2020) WAS EXPLANTED ON (B)(6) 2020. RXSIGHT'S FIRST AWARENESS DATE WAS (B)(6) 2020.

  Patient problems: Visual Disturbances

  MAUDE report 10653303 ↗