RxSight Light Adjustable Lens (RxLAL) 60005-2220Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00818806020210), received between Jul 7, 2020 and Aug 10, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Optical Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Optical Problem

  A site reported to RxSight that a patient was bilaterally implanted with pre-ActivShield Light Adjustable Lenses (LALs) and subsequently underwent one light adjustment treatment and one lock-in treatment in the right eye. Approximately 38 months later, the patient presented to a different clinic reporting blurry vision in the right eye. Upon examination, the right eye LAL was observed to have a dome-shaped finding on the anterior surface of the lens; however, the finding was not noted as significant, and a piggyback intraocular lens (IOL) was implanted to address the patient's blurry vision associated with residual hyperopia. Approximately 19 months after this procedure, the patient again reported blurry vision, and the right eye LAL was noted to exhibit a prominent dome-shaped zone. The surgeon indicated plans to explant the right eye LAL; however, it is unknown whether the explant procedure has been scheduled or performed. No additional information has been provided.

  Patient problems: Blurred Vision

  MAUDE report 50193885 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH DISTANCE VISION AND AN INTRAOCULAR LENS (+23.0D) FROM A DIFFERENT MANUFACTURER IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/05/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19680450 ↗
• InjuryNov 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  RXSIGHT RECEIVED A MEDWATCH REPORT MW5112449 DATED 10/03/2022. 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 #: 3012712027-2022-00058 FOR INFORMATION ON THE PATIENT'S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 15840884 ↗
• InjuryNov 19, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO THE PATIENT BEING DISSATISFIED WITH THE REFRACTIVE OUTCOME. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15830719 ↗
• InjuryNov 9, 2021Optical Problem; Optical Problem

  SITE REPORTED BILATERAL PATIENT HAD BOTH LIGHT ADJUSTABLE LENSES EXPLANTED AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S AWARENESS DATE WAS 10/14/2021.

  Patient problems: Visual Impairment

  MAUDE report 12778982 ↗
• InjurySep 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS HAD BEEN EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE DESIRED REFRACTIVE OUTCOME WAS NOT ACHIEVED AFTER LIGHT ADJUSTMENT TREATMENTS. RXSIGHT'S FIRST AWARENESS OF THIS WAS 8/26/2021.

  Patient problems: Visual Impairment

  MAUDE report 12510863 ↗
• InjuryAug 4, 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 12277656 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERAL PATIENT WAS INITIALLY PLANNED FOR MONOVISION (DISTANCE IN RIGHT EYE AND NEAR VISION FOR LEFT EYE), BUT AFTER IMPLANTATION AND LIGHT ADJUSTMENT TREATMENTS, THE PATIENT CHANGED HER MIND AND WANTED DISTANCE VISION FOR BOTH EYES. THE LIGHT ADJUSTABLE LENS IN THE LEFT EYE WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS IN ORDER TO ACHIEVE DISTANCE VISION IN BOTH EYES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194073 ↗
• InjuryJul 16, 2021Optical Problem; Optical Problem

  SITE REPORTED THAT THE LIGHT ADJUSTABLE LENS IN THE PATIENT'S RIGHT EYE WAS EXPLANTED AS THE PATIENT WAS EXPERIENCING DOUBLE VISION. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS 6/18/2021.

  Patient problems: Visual Impairment

  MAUDE report 12182358 ↗
• InjuryApr 21, 2021Optical Distortion; Optical Distortion

  PATIENT REPORTED A DECREASE IN VISION IN THE LEFT EYE FOLLOWING AN EVENING OUTDOORS WITHOUT UV SPECTACLE WEAR. PATIENT HAD NOT YET BEEN LOCKED IN. DOCTOR SUSPECTS PREMATURE PHOTOPOLYMERIZATION OF THE LENS. THE LENS WAS REMOVED ON (B)(6) 2021 AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 11703872 ↗
• InjuryOct 14, 2020Optical Problem; Optical Problem

  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.

  Patient problems: Visual Impairment

  MAUDE report 10681351 ↗
• InjuryJul 7, 2020Optical Distortion; Optical Distortion

  PATIENT WITH BILATERAL LIGHT ADJUSTABLE LENS IMPLANTS (LEFT EYE ON (B)(6) 2020; RIGHT EYE ON (B)(6) 2020). PATIENT REPORTED VISUAL DISTURBANCES AND NON-COMPLIANCE WITH UV PROTECTIVE WEAR. SUSPECTED BILATERAL PREMATURE PHOTOPOLYMERIZATION. BOTH LENSES WERE EXPLANTED: LEFT EYE WAS EXPLANTED ON (B)(6) 2020 AND RIGHT EYE WAS EXPLANTED ON (B)(6) 2020. BOTH LENSES ARE PENDING RETURN FOR EVALUATION.

  Patient problems: Visual Disturbances

  MAUDE report 10242980 ↗