RxSight Insertion Device 63002Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10818806021016), received between Dec 9, 2024 and Sep 10, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Use of Device Problem

  A site reported to RxSight that a patient's Light Adjustable Lens (LAL) was implanted backwards due to an error when loading the injector. The lens was removed from the eye and replaced with another LAL during the same surgery. No additional information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716743 ↗
• MalfunctionJul 21, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893544 ↗
• InjuryJul 14, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A SULCUS-PLACED LIGHT ADJUSTABLE LENS (LAL) WAS OBSERVED TO BE DECENTERED AT THE ONE-DAY POSTOPERATIVE FOLLOW-UP. DURING THE INITIAL IMPLANT PROCEDURE, THE PATIENT FIRST UNDERWENT EXPLANTATION OF A PREVIOUSLY IMPLANTED NON-RXSIGHT INTRAOCULAR LENS (IOL). DURING REMOVAL OF THE NON-RXSIGHT IOL, THE PHYSICIAN CREATED A SCLERAL TUNNEL AND ENCOUNTERED DIFFICULTY FREEING ONE EDGE OF THE LENS. THE PHYSICIAN SUBSEQUENTLY SUSPECTED THAT A NOTED CAPSULAR BAG TEAR MAY HAVE OCCURRED DURING MANIPULATION OF THE NON-RXSIGHT IOL. FOLLOWING REMOVAL OF THE PRIOR LENS, THE LAL WAS IMPLANTED IN THE SULCUS TO ACHIEVE OPTIC CAPTURE. PER REPORTED INFORMATION, NO APPARENT DEFECTS OR ISSUES WERE NOTED ON THE LAL PRIOR TO USE, THE LAL WAS LOADED INTO THE INJECTOR CORRECTLY, AND THE LAL WAS DELIVERED SUCCESSFULLY WITH NO NOTED HAPTIC DEFORMATION OR DEPLOYMENT ISSUES. AFTER THE LAL WAS OBSERVED TO BE DECENTERED AT THE ONE-DAY FOLLOW-UP, THE PHYSICIAN PERFORMED A SECONDARY SURGICAL PROCEDURE THE SAME DAY TO REPOSITION THE LAL BUT NOTED INTRAOPERATIVELY THAT ONE HAPTIC APPEARED AS IF IT HAD NOT EXPANDED. THE PHYSICIAN ATTRIBUTED THE LENS DECENTRATION TO THE SUSPECT HAPTIC AND AS

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 25815871 ↗
• MalfunctionJul 14, 2026Insufficient Device Problem Information

  THE SITE REPORTED THAT FOLLOWING COMPLETION OF LIGHT ADJUSTMENT TREATMENTS, THE PATIENT EXPERIENCED MINIMAL CHANGE IN REFRACTION AND COMPLAINED OF GLARE AND HALOS IN THE LEFT EYE. UPON EXAMINATION, THE IMPLANTED LIGHT ADJUSTABLE LENS (LAL) WAS OBSERVED TO BE IMPLANTED BACKWARDS. THE SITE REPORTED THAT THE PATIENT WAS SATISFIED WITH THEIR VISION AND THERE IS NO SURGICAL INTERVENTION PLANNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 25814696 ↗
• MalfunctionJul 8, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) FLIPPED TO AN INCORRECT ORIENTATION DURING IMPLANTATION. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751691 ↗
• MalfunctionJun 12, 2026Insufficient Device Problem Information

  A SIGHT REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS DELIVERED BACKWARDS IN THE PATIENT'S EYE. DURING THE IMPLANTATION PROCEDURE, THE PATIENT COMMUNICATED THAT THEY WERE IN DISTRESS/PAIN, REPORTEDLY RELATED TO THE PATIENT CLAMPING AND OCCLUDING THE PAIN MEDICATION LINE. THE PHYSICIAN DID NOT REMOVE OR FLIP THE LENS TO THE CORRECT ORIENTATION IN ORDER TO AVOID FURTHER PATIENT DISCOMFORT AND DUE TO THE PATIENT'S SHALLOW CAPSULAR BAG AND THE POSSIBLE RISK OF A CAPSULAR BAG RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491925 ↗
• MalfunctionJun 4, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT DURING A POST-OPERATIVE FOLLOW-UP VISIT, A PATIENT WAS FOUND TO HAVE A LIGHT ADJUSTABLE LENS (LAL) IMPLANTED IN A BACKWARDS ORIENTATION IN THE RIGHT EYE. THE LAL HAD BEEN IMPLANTED DURING A PROCEDURE WHERE A NON-RXSIGHT MULTIFOCAL IOL WAS EXCHANGED FOR THE LAL; THIS PROCEDURE WAS REPORTEDLY DIFFICULT DUE TO IRIS PROLAPSE, POOR DILATION, AND OVERALL CHALLENGING INTRAOPERATIVE MANAGEMENT, BUT THE SURGEON WAS ULTIMATELY ABLE TO IMPLANT THE LAL. DUE TO THE INTRAOPERATIVE DIFFICULTIES ENCOUNTERED DURING THE EXCHANGE PROCEDURE, THE SURGEON DOES NOT WANT TO EXPLANT OR REPOSITION THE LAL, CONSIDERING SURGICAL INTERVENTION TO BE TOO CLINICALLY RISKY.

  Patient problems: Visual Impairment

  MAUDE report 25393853 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED TO RXSIGHT THAT A PATIENT MOVED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL), WHICH LED TO THE ANTERIOR CAPSULE BEING RUPTURED. THE SURGEON WAS ABLE TO IMPLANT THE LAL INTO THE SULCUS. A VITRECTOMY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24983813 ↗
• MalfunctionApr 17, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED BACKWARDS DURING SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916741 ↗
• MalfunctionApr 16, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) FLIPPED TO AN INCORRECT ORIENTATION DURING IMPLANTATION. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899191 ↗
• MalfunctionFeb 18, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +30.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. THE SURGEON SUCCESSFULLY FLIPPED THE LENS TO THE CORRECT ORIENTATION DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379256 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6),+16.0D) WAS IMPLANTED BACKWARDS DURING SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021689 ↗
• MalfunctionDec 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED BACKWARDS DURING SURGERY. THE LENS WAS SUCCESSFULLY FLIPPED TO THE CORRECT ORIENTATION DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829708 ↗
• MalfunctionNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +27.0D) WAS IMPLANTED BACKWARDS DURING SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658803 ↗
• MalfunctionJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) +18.5D) WAS IMPLANTED BACKWARDS DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460857 ↗
• MalfunctionMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS IMPLANTED BACKWARDS DURING SURGERY. THE SURGEON DECIDED TO EXCHANGE THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574425 ↗
• MalfunctionDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RXSIGHT WAS INFORMED OF A REPORT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +26.0D) WAS IMPLANTED BACKWARDS IN THE EYE DURING A PATIENT'S PRIMARY CATARACT SURGERY. THE SURGEON EXCHANGED THE LAL FOR ANOTHER LAL DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886779 ↗