CATALYS SYSTEM CATALYS-URecalls & reported problems

Summary

The FDA's MAUDE database contains 576 adverse event reports that list this exact device (DI 05050474609792), received between Aug 29, 2016 and Sep 30, 2026 — classified as 234 injuries, 342 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (312 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 25 most recent of 576 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer Software Problem; Mechanical Problem

  Customer reported that during laser treatment on the 3rd patient, although the doctor¿s foot remained on the footswitch and the laser was firing, the system displayed the message "Laser footswitch lifted during treatment." The issue occurred toward the end of the procedure, and before the doctor could press the footswitch again, the treatment was aborted; therefore, the third procedure was not completed. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942863 ↗
• MalfunctionAug 24, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50413870 ↗
• MalfunctionAug 21, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383396 ↗
• MalfunctionAug 7, 2026Decrease in Suction

  Customer reported that their suction broke during scans and laser firing. Procedure was not completed successfully. No patient injury reported. Note: This is report 3 of 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184115 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a vitrectomy was performed due to an unspecified injury. Customer had questions on how to make the fragmentation pattern less aggressive and provided current settings. No additional information was provided.

  Patient problems: Eye Injury

  MAUDE report 50180852 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a vitrectomy was performed due to an unspecified injury. Customer had questions on how to make the fragmentation pattern less aggressive and provided current settings. No additional information was provided.

  Patient problems: Eye Injury

  MAUDE report 50180785 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a vitrectomy was performed due to an unspecified injury. Customer had questions on how to make the fragmentation pattern less aggressive and provided current settings. No additional information was provided.

  Patient problems: Eye Injury

  MAUDE report 50180744 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on the last patient, in the operating room once the cataract was completely removed, the Intraocular Lens (IOL) was in place, and surgeon was performing the final irrigation and aspiration (I/A) clean up when the patient violently moved which led to iris prolapse and the need for Miostat and sutures to close the wound on the left eye. The surgeon confirmed that the incident was not related to the laser procedure but reported it in accordance with protocol. Postoperative assessment of the patient is ongoing, and the surgeon is determining the next steps. No additional information was provided.

  Patient problems: Prolapse

  MAUDE report 50027545 ↗
• InjuryJun 18, 2026Failure to Calibrate

  IT WAS REPORTED THAT THERE WERE BUBBLES DURING DAILY ALIGNMENT VERIFICATION OF THE CATALYS LASER. IT WAS ALSO REPORTED THAT PATIENT HAD TAGS DURING CAPSULOTOMY. PATIENT HAD AN ANTERIOR VITRECTOMY PERFORMED AND THE REASON WHY VITRECTOMY WAS PERFORMED WAS NOT PROVIDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY IN THE SAME VISIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553140 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RADIAL TEAR AND CAPSULOTOMY SLIVERS IN UNKNOWN EYE AND A VITRECTOMY HAD TO BE PERFORMED DUE TO RADIAL TEAR. LASER WAS FIRING AT THE TIME OF THE INCIDENT. TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT ANY ERRORS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446115 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIPLE DOCTORS ON DIFFERENT PATIENTS, DIFFERENT DAYS HAD RADIAL TEAR AND CAPSULOTOMY SLIVERS IN UNKNOWN EYE. LASER WAS FIRING AT THE TIME OF THE INCIDENT. TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT ANY ERRORS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446101 ↗
• MalfunctionMay 26, 2026Unintended System Motion; Environmental Compatibility Problem; Unexpected Shutdown

  IT WAS REPORTED THAT CUSTOMER RECEIVED ERROR 08-035 (AMBIENT TEMPERATURE VARIATION ERROR) WHICH OCCURRED AFTER THE CAPSULOTOMY AND AT THE START OF FRAGMENTATION. THE CHAIR BECAME INACTIVE AND DOCTOR HAD TO MANUALLY LOWER THE HEADREST TO REMOVE THE PATIENT. THE TREATMENT WITH THE CATALYS LASER WAS NOT COMPLETED AND DOCTOR CHOSE TO MOVE PATIENT DIRECTLY TO THE OPERATING ROOM (OR). NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284624 ↗
• MalfunctionApr 2, 2026Computer Software Problem; Decrease in Suction

  CUSTOMER REPORTED MULTIPLE "POSSIBLE FLUID LOSS" SYSTEM WARNINGS DURING LASER FRAGMENTATION FOLLOWED BY LOSS OF VACUUM; SURGEON ABORTED THE PROCEDURE. PHYSICIAN COMPLETED CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANTATION IN THE OPERATING ROOM WITHOUT COMPLICATIONS OR NEED FOR FURTHER PROCEDURES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24771840 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A FEMTO TREATMENT DURING WHICH THE POSTERIOR CAPSULE SPLIT WHILE PHACOEMULSIFICATION WAS BEING PERFORMED. AT THE TIME OF THE INCIDENT, APPROXIMATELY 90% OF THE LENS REMAINED TO BE REMOVED. THE PHYSICIAN SUCCESSFULLY EXTRACTED MOST OF THE LENS AND PLACED A LENS IN THE EYE USING REVERSE OPTIC CAPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24620050 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR NOTICED A SMALL HOLE IN THE POSTERIOR CAPSULE THAT WAS APPROXIMATELY 1MM IN SIZE OF PATIENT'S LEFT EYE. DOCTOR ALSO REPORTED THAT THERE WAS NO VITREOUS IN THE ANTERIOR CHAMBER AND THE PATIENT WOULD BE FINE. NO ADDITIONAL SURGICAL INTERVENTIONS WERE NECESSARY. THROUGH FOLLOW UP IT WAS LEARNED THAT PATIENT IS DOING WELL. POST-OP HEALING WELL WITH NO COMPLICATIONS. DUE TO THE POSTERIOR CAPSULE OPENING, DOCTOR HAD TO LEAVE BEHIND CORTEX WHICH IS STILL OBSCURING PATIENT'S VISION BUT IT WILL LIKELY CONTINUE TO MELT AWAY WITH STEROIDS, AND IF NOT, ANOTHER PROCEDURE WILL BE PERFORMED ONCE THE INFLAMMATION RESOLVES. DOCTOR BELIEVES PATIENT WILL HAVE A GREAT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Inflammation; Unspecified Eye / Vision Problem

  MAUDE report 24552220 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CAPSULAR TEAR ON THE RIGHT EYE. THE CATARACT WAS 2+ NUCLEAR SCLEROSIS AND 3+ NUCLEAR SCLEROSIS. THERE WAS A PREVIOUS PTERYGIUM SURGERY THAT WAS PERFORMED ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24327396 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CAPSULAR TEAR ON THE LEFT EYE. THE CATARACT WAS 2+ NUCLEAR SCLEROSIS, 2+ CORTICAL AND 1+ POSTERIOR SUBCAPSULAR. THERE WAS NO PREVIOUS OCULAR SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24327158 ↗
• InjuryFeb 4, 2026Computer Software Problem

  CUSTOMER REPORTED AN INCIDENT THAT OCCURRED IN 2024, "DR. (B)(6) PATIENT UNHAPPY WITH RIGHT EYE SURGERY", THE RECORD WAS NOT AVAILABLE IN THE SYSTEM FOLLOWING A DATABASE RESET. POST-OPERATIVE EVENT WAS REPORTED, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2024 FOR REMOVAL OF RESIDUAL LENS FRAGMENTS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Discomfort

  MAUDE report 24255725 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD TO PERFORM AN ANTERIOR VITRECTOMY ON PATIENT'S RIGHT EYE AND DIDN'T KNOW WHAT WAS THE CAUSE, BUT DIDN'T FEEL THAT IT WAS CATALYS RELATED. NO ISSUES POST-OPERATIVELY WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Eye / Vision Problem

  MAUDE report 23763278 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS DROPPED AFTER CATALYS PROCEDURE OF UNKNOWN EYE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23722616 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS DROPPED AFTER CATALYS PROCEDURE OF UNKNOWN EYE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23720677 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS DROPPED AFTER CATALYS PROCEDURE OF UNKNOWN EYE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23720673 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POSTERIOR ISSUE ON THE LEFT EYE IN THE OPERATING ROOM AFTER CATALYS USE. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23700587 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CAPSULAR RADIAL TEAR. THE ANTERIOR CAPSULAR RADIAL TEAR OCCURRED AT 10 O¿CLOCK WITHOUT EXTENSION IN PATIENT'S RIGHT EYE. THE PATIENT IS DESCRIBED AS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700571 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED A CAPSULAR RADIAL TEAR OCCURRED AFTER REMOVAL OF THE CAPSULAR DISC DURING A PROCEDURE, NECESSITATING A SUBSEQUENT VITRECTOMY. THE ANTERIOR CAPSULAR RADIAL TEAR OCCURRED AT 3:30 O¿CLOCK WITH POSTERIOR CAPSULAR EXTENSION WITH VITREOUS LOSS IN PATIENT'S LEFT EYE. THE PATIENT IS DESCRIBED AS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700563 ↗