Centurion 8065751763Recalls & reported problems

Summary

The FDA's MAUDE database contains 728 adverse event reports that list this exact device (DI 00380657517633), received between Mar 2, 2021 and Sep 29, 2026 — classified as 136 injuries, 592 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (90 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 728 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Suction Problem

  A physician reported that the ophthalmic systems vacuum level did not increase as expected in ultrasound mode during phacoemulsification. The footswitch was inspected for any foreign material, and the handpiece was checked for leakage; however, no abnormalities were found. The vacuum level still did not increase thereafter. The procedure was completed without further intervention. There was no further patient impact was reported.

  Patient problems: Insufficient Information

  MAUDE report 50930863 ↗
• MalfunctionSep 25, 2026Unexpected Shutdown

  A customer reported that after cataract surgery an ophthalmic operating system was shutdown automatically while removing the cassette. The surgery was completed causing no impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897342 ↗
• MalfunctionSep 25, 2026No Device Output

  The physician reported that during surgery ophthalmic console exhibited no ultrasound power output. The issue was resolved after replacing the wire and the surgery was completed on same day without any patient health impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894261 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  A Physician reported that patient developed endophthalmitis postoperatively. Procedure details and the patient¿s clinical outcome were not reported. Additional information has been requested but none has been provided to date.

  Patient problems: Endophthalmitis

  MAUDE report 50784609 ↗
• MalfunctionSep 14, 2026No Device Output

  A customer reported that the ophthalmic system did not perform phacoemulsification. The procedure details and patient impact have not been provided.Additional information has been requested but none has been received till date.

  Patient problems: Insufficient Information

  MAUDE report 50749614 ↗
• MalfunctionSep 4, 2026Pressure Problem

  Patient problems: Insufficient Information

  MAUDE report 50611583 ↗
• MalfunctionSep 4, 2026Pressure Problem

  A customer reported that an ophthalmic operating system had poor chamber stability. Details related to patient harm have not been reported. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50610676 ↗
• MalfunctionAug 25, 2026Suction Problem; Noise, Audible

  A physician reported that during surgery while using an ophthalmic system weak aspiration was observed during ultrasound, and an abnormal noise occurred during irrigation and aspiration mode. Although the aspiration was weak, it was still functional, and the procedure was completed as planned on the same day. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431127 ↗
• InjuryAug 21, 2026Improper Flow or Infusion

  A customer reported that an ophthalmic system exhibited with irrigation malfunction which caused chamber to collapse in left eye (OS). The procedure was completed the same day with no reports of patient harm. Additional information received indicated that inadequate irrigation was observed during the phacoemulsification phase of cataract surgery, and a system message (SM) was displayed on the device during the procedure. The surgery was initially planned as cataract phacoemulsification; however, due to intraoperative complications, the procedure was converted to an anterior vitrectomy. A three-piece intraocular lens (IOL) was implanted, followed by removal of viscoelastic material. Suturing was required to complete the procedure.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 50373882 ↗
• InjuryAug 21, 2026No Device Output; Suction Problem

  A physician reported that during a femtosecond-assisted cataract extraction with intraocular lens implantation procedure on the left eye, after insertion of the phacoemulsification tip, no aspiration or phacoemulsification effect was observed and a corneal thermal injury was noted within seconds during the pre-sculpting phase before entering the nucleus. The physician reported that irrigation was functioning prior to insertion of the ophthalmic handpiece into the eye and no occlusion tone was heard. In the surgeon¿s opinion, extra heat buildup at the phacoemulsification tip contributed to the event. The thermal injury resulted in wound gaping and leakage. The ophthalmic handpiece, tubing, and cassette were exchanged, and the procedure was completed successfully on the same day. The incision was closed with ophthalmic sutures, and tissue adhesive was applied due to wound leakage. Postoperatively, mild anterior chamber shallowing, postoperative astigmatism, mild corneal opacity, and temporal corneal neovascularization were reported. The adhesive was removed and reapplied, and no further leak was reported. Follow-up treatment for astigmatism and possible release of a temporal iridocor

  Patient problems: Corneal Pannus; Corneal Scar; Eye Burn; Intraocular Pressure Decreased; Visual Impairment; Wound Dehiscence

  MAUDE report 50370113 ↗
• MalfunctionAug 17, 2026Suction Problem

  A nurse reported that during cataract surgery with intra ocular lens implantation, the ophthalmic system had unable to adequately aspirate lens material. The procedure details and patient impact have not been provided. Additional information has been requested and none received at the time of this report. This is the second of two different event date reports received from the same facility.

  Patient problems: Insufficient Information

  MAUDE report 50277268 ↗
• MalfunctionAug 14, 2026No Device Output

  Patient problems: Insufficient Information

  MAUDE report 50252016 ↗
• MalfunctionAug 7, 2026Unexpected Shutdown

  A customer reported that before the cataract with intraocular implantation surgery, ophthalmic machine shutdown on its own. Surgery has been completed by alternative machine without any patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174018 ↗
• MalfunctionAug 7, 2026Suction Problem; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173595 ↗
• MalfunctionJul 18, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25866380 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT A 79-YEAR-OLD FEMALE PATIENT UNDERWENT PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE WITH OPHTHALMIC SYSTEM , HANDPIECE , CUSTOM PAK , OPTHALMIC LENS WERE USED. DURING A POSTOPERATIVE FOLLOW-UP VISIT, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS IN THE RIGHT EYE. CLINICAL EXAMINATION REVEALED ASSOCIATED SIGNS AND SYMPTOMS INCLUDING HYPOPYON, AQUEOUS FIBRIN AND CELLULAR REACTION IN THE ANTERIOR CHAMBER, CORNEAL EDEMA, AND DECREASED VISUAL ACUITY. IN RESPONSE TO THE EVENT, THE PATIENT WAS TREATED WITH INTRAVITREAL ANTIBIOTIC INJECTIONS, STEROIDS, AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). AN ANTERIOR CHAMBER TAP WAS PERFORMED, AND CULTURE RESULTS WERE REPORTED AS NO GROWTH. AT THE TIME OF REPORTING, THE PATIENT HAD NOT RECOVERED. THIS REPORT PERTAINS TO ONE OF THREE PATIENT FOR SYSTEM ISSUE FROM SAME FACILITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Conjunctivitis; Corneal Edema; Endophthalmitis; Hypopyon

  MAUDE report 25772698 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING SCULPTING OF NUCLEUS, THERE WAS AN OCCLUSION OF PHACOEMULSIFICATION TIP WITH VISCOELASTIC CAUSING HEAT TO DISPERSE TO MAIN INCISION AND THE PATIENT EXPERIENCED CORNEAL BURN, COLLAPSING OF THE ANTERIOR CHAMBER, ASTIGMATISM AND WOUND LEAKAGE AND WHICH REQUIRES SUTURES DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON THE SAME DAY WITH SUTURES OF MAIN WOUND. THE PATIENT SYMPTOMS WERE RESOLVED. THIS IS THE ONE OF TWO PATIENTS REPORT RECEIVED FROM THE SAME FACILITY. THIS REPORT PERTAINS TO OPHTHALMIC SYSTEM INVOLVED FOR THIS EVENT.

  Patient problems: Eye Burn; Insufficient Information; Intraocular Pressure Decreased; Wound Dehiscence

  MAUDE report 25715885 ↗
• MalfunctionJul 3, 2026No Device Output

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PHACOEMULSIFICATION FUNCTION OF AN OPHTHALMIC SYSTEM WAS NOT WORKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25701733 ↗
• MalfunctionApr 23, 2026Suction Problem

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SYSTEM HAD POOR VACUUM IN QUADRANT MODE. THE SURGERY WAS CANCELLED WITHOUT ANY PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24963498 ↗
• MalfunctionApr 20, 2026Failure to Cut

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SYSTEM FAILED TO PERFORM VITRECTOMY CUTTING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24923551 ↗
• InjuryApr 16, 2026Accessory Incompatible; No Device Output; Improper Flow or Infusion; Pressure Problem

  A NURSE REPORTED THAT DURING CATARACT SURGERY, PHACOEMULSIFICATION STOPPED MID CASE IN AN OPHTHALMIC SYSTEM. THE SYSTEM DISPLAYED A SYSTEM MESSAGE AND EJECTED THE FLUIDICS MANAGEMENT SYSTEM (FMS). THE PATIENT EXPERIENCED EYE COLLAPSE AND REQUIRED SUTURES. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER RESTARTING THE SYSTEM WITH A NEW FMS AND A BALANCED SALT SOLUTION BAG. THE PATIENT¿S CURRENT CONDITION WAS UNKNOWN. THIS REPORT PERTAINS TO OPHTHALMIC SYSTEM INVOLVED FOR THIS REPORTED EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 24895834 ↗
• MalfunctionApr 11, 2026Audible Prompt/Feedback Problem; Suction Failure

  A NURSE MANAGER REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION AT THE START OF THE PHACOEMULSIFICATION (PHACO), AN OPHTHALMIC OPERATING SYSTEM DID NOT PROVIDE ASPIRATION, AND THE OCCLUSION TONE WAS NOT HEARD. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER MACHINE WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852029 ↗
• MalfunctionApr 10, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC CONSOLE EXHIBITED WEAK ASPIRATION DURING ULTRASOUND MODE. THE SURGERY WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO IMPACT ON THE PATIENT. NO FURTHER INFORMATION IS EXPECTED, AS THE CUSTOMER WAS UNWILLING TO PROVIDE ADDITIONAL DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839364 ↗
• MalfunctionApr 8, 2026Restricted Flow rate; Improper Flow or Infusion

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SYSTEM EXHIBITED HIGH REFLUX AND POOR IRRIGATION. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24813651 ↗
• MalfunctionMar 30, 2026No Device Output

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY AN OPHTHALMIC SYSTEM AND HANDPIECES WERE USED WHICH DOES NOT PRODUCE ULTRASOUNDS. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24713859 ↗