Centurion 8065751762Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380657517626), received between Nov 13, 2021 and Feb 13, 2026 — classified as 22 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Reflux within Device” (4 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Wireless Communication Problem

  A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION WHILE USING AN OPHTHALMIC FOOT SWITCH WITH THE SYSTEM AN ADVISORY WAS DISPLAYED DURING AN ATTEMPT TO ACTIVATE THE ULTRASOUND (US) FUNCTION, AND THE PROCEDURE WAS DISCONTINUED. THE CONTINUATION OF THE SURGERY WAS PERFORMED AND COMPLETED AT A NEARBY UNIVERSITY HOSPITAL ON THE SAME DAY. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24331057 ↗
• InjuryDec 18, 2025Wireless Communication Problem; Wireless Communication Problem

  A PHYSICIAN REPORTED THAT DURING THE SURGERY THE SYSTEM MESSAGE WAS DISPLAYED AT CONJUNCTIVAL INCISION COAGULATION PHASE AND THE SURGERY WAS ABORTED. THE PATIENT WAS SCHEDULED FOR REOPERATION AND COMPLETED THE SURGERY WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839557 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT'S CONDITION IS IMPROVING. THERE WAS NO INFLAMMATION.

  Patient problems: Intraocular Pressure Increased; Posterior Capsule Opacification

  MAUDE report 20901257 ↗
• InjuryDec 4, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  A PHYSICIAN REPORTED THAT DURING SURGERY, THE SYSTEM WAS DISPLAYED AN ERROR MESSAGE. THE SURGERY WAS CANCELLED AND REOPERATION WAS PERFORMED AT ANOTHER HOSPITAL ON THE FOLLOWING DAY. OUTCOME OF THE PATIENT WAS NOT REPORTED. THE REPORTER ALSO CONFIRMED THAT NO FOREIGN OBJECTS WERE TRAPPED. THE DETAILS OF THE PROCEDURE WAS NOT PROVIDED.

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

  MAUDE report 20841399 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC SYSTEM ERROR MESSAGE WAS DISPLAYED AND COULD NOT BE USED. THE INCISION ON THE PATIENT EYE HAD ALREADY STARTED AND FOOT SWITCH COMPLETELY STOPPED WORKING. THE SURGERY WAS CANCELLED, PATIENT RETURN TO THE WARD AND REOPERATION WAS CONSIDERED. OUTCOME OF THE PATIENT WAS NOT REPORTED.

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

  MAUDE report 20389798 ↗
• InjuryApr 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY, WHEN THE SURGEON TRIED TO USE THE OPHTHALMIC CONSOLE, AN ERROR MESSAGE APPEARED ABOUT A FOOT SWITCH FAILURE. EVEN AFTER TRYING MANY TIMES TO FIX, IT, THE PROBLEM DIDN'T GET BETTER, SO THE SURGERY HAD TO BE CANCELED. THIS HAPPENED AFTER THE SURGEON HAD ALREADY CUT THE PATIENT'S CONJUNCTIVA AND TRIED TO USE COAGULATION TO STOP BLEEDING. SINCE THE SITUATION HAS NOT IMPROVED THE SURGERY WAS CANCELLED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE REOPERATION WAS PERFORMED AND COMPLETED ON ANOTHER DAY WITHOUT ANY PROBLEMS.

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

  MAUDE report 19041065 ↗
• InjuryMar 21, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOOTSWITCH NO LONGER WORKED AND DISPLAYED ERROR CODE DURING CORTEX STEP AND OPHTHALMIC OPERATING CONSOLE HAD IRRIGATION/ASPIRATION ISSUES, SO SURGEON HAD TO DO MANUALLY DURING CATARACT SURGERY AND PUT A SUTURE ON THE CORNEA (EYE UNKNOWN) OF THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A DELAY OF ONE HOUR. THE PATIENT ALSO EXPERIENCED CORNEAL EDEMA AND SUTURE ASSOCIATED ASTIGMATISM. THE CURRENT CONDITION OF THE PATIENT WAS IMPROVING FROM THE REPORTED EVENTS.

  Patient problems: Corneal Edema; Visual Disturbances

  MAUDE report 18948219 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SYSTEM EXHIBITED SYSTEM MESSAGE DURING A CATARACT SURGERY. SURGERY WAS CANCELLED AND PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND IT WAS COMPLETED. PATIENT CONDITION IS UNKNOWN.

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

  MAUDE report 18264240 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING FOOTSWITCH EXHIBITED SYSTEM MESSAGE DURING SURGERY. THE PATIENT'S SURGERY WAS NOT FINALIZED, THE PATIENT TRANSFERRED TO ANOTHER HOSPITAL.

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

  MAUDE report 18235886 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Key or Button Unresponsive/not Working; Adverse Event Without Identified Device or Use Problem; Key or Button Unresponsive/not Working

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FOOT PEDAL DID NOT RESPOND DURING SURGERY, THE PATIENT¿S EYE WAS OPEN FOR SO LONG, A LOT OF CORNEAL EDEMA DEVELOPED, WHICH RESULTED IN VERY LIMITED VISION. THE PROCEDURE DETAILS WAS NOT REPORTED. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NON RECEIVED TILL DATE.

  Patient problems: Corneal Edema; Unspecified Eye / Vision Problem

  MAUDE report 18092035 ↗
• InjuryOct 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT OPHTHALMIC OPERATING FOOTSWITCH DISPLAYED AN ADVISORY CODE DUE TO WHICH THE CATARACT SURGERY WAS ABORTED AND COMPLETED ON THE NEXT DAY WITH THE SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM.

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

  MAUDE report 17964985 ↗
• InjuryJul 27, 2023Defective Component; Defective Component

  A PHYSICIAN REPORTED THAT DURING A PROCEDURE A FOOTSWITCH WAS FAILED WITH A SYSTEM MESSAGE. POST CONJUNCTIVAL INCISION WHEN THE BIPOLAR WAS ABOUT TO USE THE FOOTSWITCH WAS INOPERABLE. PROCEDURE WAS ABORTED AND COMPLETED ON THE NEXT DAY WITHOUT ANY REPORT OF PATIENT HARM. THIS REPORT REPRESENTS THE FOOTSWITCH INVOLVED IN THE EVENT.

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

  MAUDE report 17403677 ↗
• MalfunctionJul 18, 2023Reflux within Device; Reflux within Device

  A CUSTOMER REPORTED AN OPHTHALMIC OPERATING CONSOLE AND FOOTSWITCH PRESENTED NO REFLUX. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341014 ↗
• InjuryJun 9, 2023Defective Component; Defective Component

  A CUSTOMER REPORTED THAT WHILE PERFORMING CATARACT SURGERY AN OPHTHALMIC CONSOLE FOOT SWITCH BECOME UNRESPONSIVE. THE CASE WAS ABANDONED WITH 20% OF CATARACT STILL TO BE REMOVED AND THE CUSTOMER BORROWED A FOOTSWITCH FROM ANOTHER HOSPITAL AND BROUGHT THE PATIENT BACK TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 17097402 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY SYSTEM MESSAGE WAS DISPLAYED AND NOTHING CAN BE DONE TO RESOLVE IT, PATIENTS CONJUNCTIVA WAS INCISED BUT BECAUSE OF THE ERROR, WOUND WAS CLOSED AND SURGERY WAS POSTPONED. PATIENT HARM WAS NOT REPORTED.

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

  MAUDE report 17079052 ↗
• MalfunctionMay 26, 2023Reflux within Device; Reflux within Device

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING HANDPIECE WAS GETTING OCCLUDED ON THE POSTERIOR CAPSULE AND SURGICAL FOOTSWITCH WAS NOT RELEASING REFLUX. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012220 ↗
• MalfunctionMay 26, 2023Reflux within Device; Reflux within Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC HANDPIECE WAS NOT RELEASING CAPSULAR BAG AND OPHTHALMIC OPERATING FOOTSWITCH HAD REFLUX ISSUE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011894 ↗
• MalfunctionMay 8, 2023Reflux within Device; Reflux within Device

  ADDITIONAL INFORMATION HAS BEEN RECEIVED WITH UPDATED SUSPECT PRODUCT DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885073 ↗
• InjuryApr 21, 2023Wireless Communication Problem; Wireless Communication Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT WHILE PHACOEMULSIFICATION OF THE THIRD SEGMENT THE FOOT PEDAL LOST CONNECTION WITH THE OPHTHALMIC CONSOLE THE PHYSICIAN TRIED TO RECONNECT THE FOOT PEDAL AND ASKED THE STAFF FOR MAIN CORD, CORED WAS NOT LOCATED QUICK ENOUGH TO COMPLETE THE PROCEDURE WHICH RESULTED CHOROIDAL BLEEDING. THE PROCEDURE WAS NOT COMPLETED. EYE WAS SUTURED, DIURETIC AND TOPICAL MEDICATIONS WERE USED TO STABILIZE THE EYE. PATIENT TO RETURN ON ANOTHER DAY TO HAVE PROCEDURE COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16784877 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY AN ERROR CODE WAS DISPLAYED IN CONSOLE, THE ERROR CODE RECURRED EVEN AFTER MAKING THE WIRED CONNECTION WITH FOOT PEDAL AND RESTARTING THE CONSOLE. THE SURGERY WAS COMPLETED USING SAME CONSOLE. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT THE PATIENT HAS EXPERIENCED CORNEAL ENDOTHELIAL CELL LOSS.

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

  MAUDE report 16686025 ↗
• MalfunctionMar 15, 2023Backflow; Appropriate Device Problem Term/Code Not Available; Backflow; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THERE WAS NO REFLUX, THE REPORTER SUSPECTED POSSIBLE FOOTSWITCH SIDE SWITCH INTERMITTENT PROBLEM, BUT NO SYSTEM MESSAGES OCCURRED. ADDITIONAL INFORMATION HAD BEEN REQUESTED WITH NONE PROVIDED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543011 ↗
• InjuryFeb 17, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WHILE USING AN OPHTHALMIC FOOT PEDAL AN ERROR MESSAGE WAS DISPLAYED AND PEDAL STOPPED WORKING. SURGERY WAS COMPLETED AFTER TAKING NEW PEDAL AND PATIENT HAS EXPERIENCED CORNEAL EDEMA AND MEDICATION WAS GIVEN.

  Patient problems: Corneal Edema

  MAUDE report 16396118 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WHILE USING OPHTHALMIC FOOTSWITCH ERROR CODE DISPLAYED AND PRODUCT BECAME UNUSABLE. SURGERY WAS CANCELLED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING THE SURGERY COMPLETED THE NEXT DAY USING ALTERNATE ACCESSORY.

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

  MAUDE report 16252568 ↗
• InjuryNov 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE A CATARACT SURGERY SYSTEM MESSAGE WAS DISPLAYED AFTER CAPSULORHEXIS WAS DONE. THE SURGERY WAS POSTPONED TO NEXT DAY. SURGERY WAS COMPLETED AFTER FOOTPEDAL WAS BORROWED.

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

  MAUDE report 15825819 ↗
• InjuryJun 15, 2022Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL TREATED WITH AN OPHTHALMIC CONSOLE FOOT PEDAL FAILED DURING CATARACT SURGERY WHICH LED TO CORNEAL EDEMA AND ANTERIOR CHAMBER INFLAMMATION. CORNEAL EDEMA WAS RESOLVE BUT STILL HAD MILD INFLAMMATION IN THE ANTERIOR CHAMBER WHICH IS WAS TREATED WITH STEROID DROPS. THE SURGERY WAS COMPLETED BY REPLACING THE FOOT PEDAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Inflammation

  MAUDE report 14694131 ↗