RxSight Injector Handpiece 63001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00818806020005), received between Mar 19, 2025 and Sep 17, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Use of Device Problem

  Patient problems: Capsular Bag Tear

  MAUDE report 50807897 ↗
• InjuryJul 21, 2026Insufficient Device Problem Information

  A SITE REPORTED THAT, DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL), THE LENS WAS INADVERTENTLY IMPLANTED BACKWARDS. THE SURGEON WAS ABLE TO FLIP THE LAL TO THE CORRECT ORIENTATION; HOWEVER, A CAPSULAR BAG TEAR OCCURRED. A VITRECTOMY WAS PERFORMED, AND THE LAL WAS SUBSEQUENTLY IMPLANTED IN THE SULCUS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25893547 ↗
• MalfunctionJul 10, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT UPON INSERTION OF A LIGHT ADJUSTABLE LENS (LAL) THE LENS FLIPPED TO THE WRONG ORIENTATION AND DUE TO THE PATIENT'S ANTERIOR CHAMBER BEING TOO SHALLOW, THE LENS COULD NOT BE FLIPPED TO THE CORRECT ORIENTATION. THE LAL WAS EXCHANGED FOR A NEW LAL DURING THE SAME PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781800 ↗
• MalfunctionJun 30, 2026Insufficient Device Problem Information

  A SITE REPORTED THAT A PATIENT'S LEFT EYE EXHIBITED NO REFRACTIVE CHANGE AFTER THREE LIGHT ADJUSTMENT PROCEDURES. SUBSEQUENT EXAMINATION IDENTIFIED THAT THE LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED BACKWARDS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25666752 ↗
• MalfunctionJun 3, 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 25375538 ↗
• MalfunctionMay 27, 2026Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL) WAS INADVERTENTLY IMPLANTED BACKWARDS. THE SITE COMPLETED ALL LIGHT TREATMENTS FOR THE PATIENT BEFORE REALIZING THAT THE ORIENTATION OF THE LAL WAS INCORRECT. THE SURGEON BELIEVES THAT HE WAS NOT ROTATING THE HANDPIECE ENOUGH DURING OPTIC DELIVERY. HOWEVER, THE PATIENT IS HAPPY WITH THEIR CURRENT VISION, AND THERE IS NO PLAN TO EXCHANGE OR REPOSITION THE LENS AS YAG CAPSULOTOMY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306165 ↗
• MalfunctionMay 22, 2026Insufficient Device Problem Information

  RXSIGHT BECAME AWARE THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS IMPLANTED BACKWARDS IN THE LEFT EYE AFTER A SITE REPORTED ATTEMPTING 2 LIGHT TREATMENTS WITH NO REFRACTION CHANGE. THE PATIENT IS SATISFIED WITH VISION AND NO ADDITIONAL SURGERY IS PLANNED TO CORRECT THE ORIENTATION OF THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262767 ↗
• MalfunctionMay 22, 2026Insufficient Device Problem Information

  RXSIGHT BECAME AWARE THAT A PATIENT'S LIGHT ADJUSTABLE LENS WAS IMPLANTED BACKWARDS IN THE RIGHT EYE AFTER A SITE REPORTED ATTEMPTING 2 LIGHT TREATMENTS WITH NO REFRACTION CHANGE. THE PATIENT IS SATISFIED WITH VISION AND NO ADDITIONAL SURGERY IS PLANNED TO CORRECT THE ORIENTATION OF THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262763 ↗
• MalfunctionMar 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RXSIGHT WAS INFORMED THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +16.0D) WAS IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. NO SECONDARY SURGICAL INTERVENTION IS CURRENTLY PLANNED PER THE TREATING PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644976 ↗