Centurion, OZil 8065751761Recalls & reported problems

Summary

The FDA's MAUDE database contains 475 adverse event reports that list this exact device (DI 00380657517619), received between Mar 3, 2021 and Sep 14, 2026 — classified as 76 injuries, 399 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (143 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 25 most recent of 475 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Output below Specifications; Excessive Heating

  A customer reported that an ophthalmic handpiece was overheated during cataract surgery. The surgery was completed by using another handpiece. There was no patient harm.This report pertains to two of two different event dates received from the same facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50751773 ↗
• MalfunctionSep 10, 2026Output below Specifications; Excessive Heating

  A health care professional reported that an ophthalmic handpiece got very hot but delivers hardly any power during cataract surgery. There was no patient harm.This report pertains to one of two different event dates received from the same facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714676 ↗
• MalfunctionAug 10, 2026No Device Output

  A physician reported that during cataract surgery, the ophthalmic handpiece did not provide energy output, and the nucleus could not be emulsified. The surgery was completed after replacing with another handpiece on the same day. No patient impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190020 ↗
• MalfunctionAug 5, 2026Suction Problem; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139231 ↗
• InjuryJul 22, 2026No Device Output; Suction Problem; Excessive Heating

  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 25908268 ↗
• MalfunctionJul 6, 2026No Device Output

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC HANDPIECE FAILED TO DELIVER POWER FOLLOWING TUNING DURING SURGERY. NO SYSTEM MESSAGES WERE OBSERVED. 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 25716855 ↗
• MalfunctionJun 26, 2026Suction Problem

  A CUSTOMER REPORTED THAT TWO OPHTHALMIC HANDPIECES DOESN¿T VACUUM OR MAKE A GROOVE DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING ANOTHER HANDPIECE. 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 25634777 ↗
• MalfunctionMay 12, 2026Break; Suction Problem

  A PHYSICIAN REPORTED THAT, DURING PHACOEMULSIFICATION (PHACO) MODE OF THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AN OPHTHALMIC HANDPIECE WAS UNABLE TO BUILD VACUUM INTERMITTENTLY AND THE HANDPIECE WAS OBSERVED WITH BULGED CABLE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER HANDPIECE AND THERE WAS NO PATIENT HARM. 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 25148193 ↗
• MalfunctionApr 20, 2026Suction Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY, AN OPHTHALMIC HANDPIECE EXHIBITED POOR ASPIRATION IN THE PHACO MODE. THE SURGERY WAS CONTINUED AND COMPLETED WITHOUT ANY OTHER ISSUES. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24923544 ↗
• MalfunctionMar 30, 2026No Device Output

  THE PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AN OPHTHALMIC HANDPIECE UNABLE TO DELIVER ULTRASOUND. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724754 ↗
• MalfunctionMar 30, 2026Suction Problem; Excessive Heating

  A NURSE REPORTED THAT TWO DIFFERENT OPHTHALMIC HANDPIECES WERE HEATING UP AND THAT THERE WAS NO ASPIRATION IN PHACOEMULSIFICATION MODE. DETAILS OF THE PROCEDURE AND ANY POTENTIAL PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS IS THE FIRST OF TWO REPORTS RECEIVED FROM THE SAME REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 24712740 ↗
• 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 24712452 ↗
• MalfunctionMar 13, 2026Excessive Heating

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC HANDPIECE GOT HEATED. 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 24589106 ↗
• MalfunctionMar 6, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY, AN OPHTHALMIC HANDPIECE FAILED TO ASPIRATE IN THE PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A NEW HANDPIECE, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531410 ↗
• MalfunctionFeb 16, 2026No Device Output

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE HAD A FAILURE OF PHACOEMULSIFICATION FUNCTION DURING SURGERY. THE SURGERY WAS COMPLETED BY SWITCHING TO ANOTHER HANDPIECE ON THE SAME DAY. THERE WAS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342984 ↗
• MalfunctionJan 27, 2026Excessive Heating

  A PHYSICIAN REPORTED THAT, BEFORE SURGERY AN OPHTHALMIC HANDPIECE WAS FOUND GETTING OVERHEATED. PROCEDURE DETAILS WERE NOT REPORTED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ALTERNATIVE HANDPIECE WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186847 ↗
• MalfunctionJan 20, 2026No Device Output; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR IMPLANT PROCEDURE, THE OPHTHALMIC HANDPIECE WAS ASPIRATING INTERMITTENTLY, BUT THERE WAS NO CUTTING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER PHACO PROBE. THE PATIENT IMPACT HAS NOT BEEN PROVIDED. THIS REPORT PERTAINS TO THE OPHTHALMIC HANDPIECE INVOLVED IN THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24113611 ↗
• MalfunctionDec 31, 2025No Device Output; No Device Output

  ADDITIONAL INFORMATION INDICATES THAT THE SURGERY WAS COMPLETED BY REPLACING THE OPHTHALMIC HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932326 ↗
• MalfunctionDec 19, 2025No Device Output; No Device Output

  A CUSTOMER REPORTED THAT DURING THE PROCEDURE THE OPHTHALMIC HANDPIECE DID NOT WORK AND NO ULTRASOUNDS. THE SURGERY WAS COMPLETED BY REPLACING THE HANDPIECE WITH ANOTHER ONE. DETAILS OF SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23847283 ↗
• MalfunctionDec 18, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT DURING A CATARACT EXTRACTION IN PHACOEMULSIFICATION (PHACO) MODE, AN OPHTHALMIC HANDPIECE (HP) EXHIBITED WITH A LACK IN VACUUM STRENGTH. ALSO, DURING THE CORTICAL PHASE, SCREEN INDICATED THAT THE VACUUM INCREASED BUT THE STRENGTH DECREASED. THE SAME ISSUE OCCURRED DURING VISCOELASTIC ASPIRATION PHASE TOO. THE SURGERY WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. FOR THE NEXT SURGERY EQUIPMENT WAS RESTARTED AND THE CASSETTE WAS REPLACED AFTER WHICH IT FUNCTIONED NORMALLY. THIS REPORT PERTAINS TO HANDPIECE INVOLVED IN REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838274 ↗
• MalfunctionDec 3, 2025No Device Output; No Device Output

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY IN AN OPHTHALMIC HANDPIECE THERE WAS ULTRASOUND. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE HANDPIECE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703688 ↗
• InjuryNov 25, 2025Obstruction of Flow; Excessive Heating; Obstruction of Flow; Excessive Heating

  THE NURSE REPORTED THAT THE FEMALE PATIENT DURING CATARACT SURGERY ON THE RIGHT EYE OPHTHALMIC HANDPIECE PHACO TIP GOT VERY HOT AND THE PATIENT EXPERIENCED CORNEAL BURN WHICH RESULTS IN WOULD LEAKAGE. THE PATIENT HAD SUTURING AS SURGICAL INTERVENTION. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN.

  Patient problems: Blurred Vision; Eye Burn; Wound Dehiscence

  MAUDE report 23644926 ↗
• MalfunctionNov 24, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION PHACOEMULSIFICATION PHASE OF SURGERY HANDPIECE WAS NOT ASPIRATED PROPERLY AND EXHIBITED EXCESSIVE BUBBLES. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE HANDPIECE WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631390 ↗
• MalfunctionNov 20, 2025Excessive Heating; Excessive Heating

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC HANDPIECE QUICKLY BECAME VERY HOT. THE SURGERY WAS COMPLETED USING A DIFFERENT HANDPIECE CAUSING NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606160 ↗
• MalfunctionOct 23, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT IN THE DURING CATARACT PROCEDURE AT THE START OF SCULPT PHASE THE HANDPIECE WAS OCCLUDED IMMEDIATELY AND CONTINUED TO ALARM WITH NO ASPIRATION. THE SURGEON PAUSED THE PROCEDURE AND REPLACED WITH ANOTHER HANDPIECE. THE SURGERY WAS CONTINUED AS PLANNED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366017 ↗