RxSight Light Adjustable Lens (RxLAL) 60005-2225Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818806020227), received between Feb 7, 2020 and Mar 14, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Optical Distortion” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6),+22.5D) WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21612640 ↗
• InjuryNov 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  RXSIGHT RECEIVED A MEDWATCH REPORT MW5112449 DATED (B)(6) 2022. A PATIENT STATED THAT THEY HAD THE LIGHT ADJUSTABLE LENSES (LALS) IMPLANTED AND THEY ARE "ESSENTIALLY VISUALLY IMPAIRED FOR DISTANCE VISION". THE PATIENT HAD A HISTORY OF COMPLAINTS RELATED TO SEVERE BLURRY VISION FOR YEARS PRIOR TO IMPLANTATION OF THE LALS AND A HISTORY OF NOT TOLERATING MONOVISION CORRECTION. THE RIGHT EYE (OD) WAS IMPLANTED ON (B)(6) 2021 WITH LAL SERIAL NUMBER (B)(4). THE LEFT EYE (OS) WAS IMPLANTED ON (B)(6) 2021 WITH LAL SERIAL NUMBER (B)(4). DURING LIGHT ADJUSTMENT TREATMENTS, THE PATIENT REQUESTED ADDITIONAL MYOPIA IN THE LEFT EYE. REFER TO MFR REPORT #: 3012712027-2022-00057 FOR INFORMATION ON THE PATIENT'S RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 15840973 ↗
• InjuryJun 8, 2022Optical Problem; Optical Problem

  SITE REPORTED PATIENT HAD THE LIGHT ADJUSTABLE LENS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. ANOTHER LAL WAS IMPLANTED DURING THE EXCHANGE ON (B)(6) 2022. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 5/12/2022.

  Patient problems: Visual Impairment

  MAUDE report 14633624 ↗
• InjuryJan 28, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THE EVENT OCCURRED ON 12/29/2020.

  Patient problems: Visual Impairment

  MAUDE report 11245137 ↗
• InjuryNov 17, 2020Optical Distortion; Optical Distortion

  PATIENT ADMITTED TO NOT WEARING POST OPERATIVE UV SPECTACLES INDOORS AFTER CATARACT SURGERY, RESULTING IN PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE SURGEON EXPLANTED THE LENS AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 10857309 ↗
• InjuryMay 27, 2020Optical Distortion; Optical Distortion

  PATIENT WITH A LIGHT ADJUSTABLE LENS IN THE LEFT EYE COMPLAINED OF BLURRY VISION WITH LOTS OF GLARE. UPON EXAMINATION, A CENTRAL ISLAND 2-3 MM IN SIZE WAS NOTED NEAR THE CENTER OF THE LENS, WHICH IS INDICATIVE OF EXPOSURE TO UV LIGHT. UPON FOLLOW-UP IT WAS NOTED THAT THE PATIENT WAS NOT COMPLIANT WITH UV SPECTACLE WEAR. THE LENS WAS EXPLANTED ON (B)(6) 2020 (RXSIGHT BECAME AWARE ON 5/6/2020). THE EXPLANTED LENS WAS DISCARDED AT THE SITE.

  Patient problems: Visual Disturbances

  MAUDE report 10094278 ↗
• InjuryMay 12, 2020Optical Distortion; Optical Distortion

  PATIENT WITH BILATERAL LIGHT ADJUSTABLE LENS IMPLANTS PRESENTED DURING A PREADJUSTMENT VISIT WITH DECREASED BEST CORRECTED VISUAL ACUITY (20/60 IN RIGHT EYE, 20/100 IN LEFT EYE). FAMILY MEMBER PRESENT INDICATED THAT PATIENT WAS NOT COMPLIANT WITH UV SPEC WEAR DURING WAKING HOURS. BOTH LENSES WERE EXPLANTED: RIGHT EYE EXPLANTED ON 4/16/2020 - THE LENS WAS DISCARDED AT THE SITE; THE LEFT EYE WAS EXPLANTED ON 5/5/2020 AND IS PENDING RETURN FOR EVALUATION.

  Patient problems: Visual Disturbances

  MAUDE report 10047901 ↗
• InjuryMar 27, 2020Optical Distortion; Optical Distortion

  PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY IN BOTH EYES IN (B)(6) 2019. PATIENT RETURNED APPROXIMATELY ONE MONTH POST-LOCK-IN INDICATING THAT THE VISION IN HER RIGHT EYE HAD CHANGED. LEFT EYE REFRACTION REMAINED UNCHANGED. THE PATIENT'S DOCTOR ELECTED TO EXPLANT THE LENS AND IMPLANT WITH ANOTHER LIGHT ADJUSTABLE LENS. THE MANUFACTURER'S FIRST AWARENESS OF THE EXPLANT WAS 2/29/2020.

  Patient problems: Visual Disturbances

  MAUDE report 9892014 ↗
• InjuryMar 16, 2020Optical Distortion; Optical Distortion

  FOLLOWING SUCCESSFUL CATARACT SURGERY AND IMPLANTATION OF THE LIGHT ADJUSTABLE LENS ((B)(6) 2019 FOR THE LEFT EYE; (B)(6) 2019 FOR THE RIGHT EYE) AND COMPLETION OF LIGHT TREATMENTS OF THE LENSES FOR BOTH EYES, THE PATIENT COMPLAINED OF VISUAL DISTURBANCES IN THE LEFT EYE ONLY. PATIENT WAS DETERMINED TO HAVE IRREGULAR ASTIGMATISM IN THE LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2020 (MANUFACTURER'S FIRST AWARENESS DATE WAS (B)(6) 2020) AND A NEW LIGHT ADJUSTABLE LENS WAS IMPLANTED.

  Patient problems: Visual Disturbances

  MAUDE report 9835314 ↗
• InjuryFeb 7, 2020Optical Distortion; Optical Distortion

  PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE LIGHT ADJUSTABLE LENS ON (B)(6) 2019. PATIENT UNDERWENT FIRST AND SECOND ADJUSTMENTS WITHOUT PROBLEMS. AFTER SECOND ADJUSTMENT, PATIENT DID NOT CONTINUE TO WEAR THE PROVIDED UV PROTECTIVE EYEWEAR AFTER MISUNDERSTANDING INSTRUCTIONS. PATIENT TOOK AN OUTDOOR EXCURSION ON A BRIGHT DAY WITHOUT PROVIDED UV PROTECTIVE EYEWEAR AND REPORTED A DECREASE IN VISION THE FOLLOWING DAY DUE TO THE UNANTICIPATED POLYMERIZATION OF THE LENS. THE POLYMERIZATION RESULTED IN DECREASED VISUAL ACUITY AND VISUAL DISTURBANCES (GLARE AND HALO), PARTICULARLY IN THE LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2019 AND MANUFACTURER WAS MADE AWARE OF EVENT ON 2/6/2020.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 9683210 ↗