Ozil 8065750469Recalls & reported problems

Summary

The FDA's MAUDE database contains 261 adverse event reports that list this exact device (DI 00380657504695), received between Mar 7, 2021 and Aug 14, 2026 — classified as 100 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (69 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 261 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Suction Problem

  A healthcare professional reported that an ophthalmic handpiece exhibited no suction during the phacoemulsification mode. The surgical procedure was completed successfully without any impact on the patient.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 50251251 ↗
• InjuryApr 9, 2026Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE EXHIBITED NO ASPIRATION IN CORTEX WITH ASPIRATION AND IRRIGATION (I/A) MODE. A SUDDEN CHAMBER FLUCTUATION LED TO A CAPSULAR RUPTURE. EMERGENCY SURGERY WAS REQUIRED, FOLLOWED BY SECONDARY IMPLANTATION. THE IA HANDPIECE AND TIP WERE REPLACED. THERE WAS NO REPORTS OF PROCEDURE TYPE. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. THE PROCEDURE TYPE WAS UNKNOWN. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN. THIS IS THE THIRD OF SIX OPHTHALMIC HANDPIECE REPORTS RECEIVED FROM THE SAME REPORTER. THIS REPORT PERTAINS TO OPHTHALMIC HANDPIECE INVOLVED FOR THIS REPORTED EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 24829103 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO OPHTHALMIC HANDPIECE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Eye Burn; Wound Dehiscence

  MAUDE report 24092812 ↗
• InjuryDec 16, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE EXHIBITED NO ASPIRATION IN CORTEX WITH ASPIRATION AND IRRIGATION (I/A) MODE. A SUDDEN CHAMBER FLUCTUATION LED TO A CAPSULAR RUPTURE. EMERGENCY SURGERY WAS REQUIRED, FOLLOWED BY SECONDARY IMPLANTATION. THE IA HANDPIECE AND TIP WERE REPLACED. THERE WAS NO REPORTS OF PROCEDURE TYPE. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN.

  Patient problems: Capsular Bag Tear

  MAUDE report 23814929 ↗
• InjuryDec 3, 2025Obstruction of Flow; Excessive Heating; Obstruction of Flow; Excessive Heating

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE WAS HOT WITH WHITE SMOKE EMANATED FROM THE TIP. THE PATIENT HAS EXPERIENCED CORNEAL WOUND BURN AND ALSO CORNEA OPACIFIED WITH A SMALL GAP DURING THE PROCEDURE IN THE LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER HANDPIECE. THE PATIENT CONDITION IS IMPROVING.

  Patient problems: Corneal Clouding/Hazing; Eye Burn; Intraocular Pressure Decreased

  MAUDE report 23704031 ↗
• MalfunctionNov 24, 2025Improper Flow or Infusion; Suction Failure; Improper Flow or Infusion; Suction Failure

  A NURSE REPORTED THAT AN OPHTHALMIC HANDPIECE EXHIBITED NO ASPIRATION AND IRRIGATION BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH AN ALTERNATE HANDPIECE ON SAME DAY. THIS REPORT PERTAINING TO TWO OF THE TWO REPORTS FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630346 ↗
• MalfunctionNov 24, 2025No Device Output; No Device Output

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE PASSED TESTING AND TUNING, BUT THERE WERE NO ULTRASOUNDS OUTPUT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A DIFFERENT HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628643 ↗
• MalfunctionNov 14, 2025Excessive Heating; Excessive Heating

  A CUSTOMER REPORTED THAT BEFORE SURGERY AN OPHTHALMIC HANDPIECE WAS OVERHEATING AND NOT FUNCTIONING PROPERLY. PROCEDURE DETAILS WERE NOT PROVIDED, AND NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553968 ↗
• InjuryNov 14, 2025No Device Output; No Device Output

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRA OCULAR LENS IMPLANT (IOL) AN OPHTHALMIC HANDPIECE DID NOT WORK, AND PHACOEMULSIFICATION (PHACO) POWER WAS NOT THERE AS A RESULT CORNEAL BURN, CORNEAL OEDEMA AROUND THE MAIN INCISION WHERE THE PHACO TIP CAUSED CORNEAL BURN WHICH REQUIRED TWO SUTURES AND BANDAGE AS LEAK OCCURRED WHICH GOT RESOLVED AFTER ONE WEEK. HANDPIECE AND PACK WERE CHANGED.

  Patient problems: Corneal Edema; Eye Burn; Wound Dehiscence

  MAUDE report 23552773 ↗
• InjuryNov 12, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE EXHIBITED NO ASPIRATION IN CORTEX WITH ASPIRATION AND IRRIGATION (I/A) MODE. A SUDDEN CHAMBER FLUCTUATION LED TO A CAPSULAR RUPTURE. EMERGENCY SURGERY WAS REQUIRED, FOLLOWED BY SECONDARY IMPLANTATION. THE IA HANDPIECE AND TIP WERE REPLACED. THERE WAS NO REPORTS OF PROCEDURE TYPE. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN

  Patient problems: Capsular Bag Tear

  MAUDE report 23530567 ↗
• MalfunctionOct 30, 2025No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT DURING THE SURGERY AN OPTHALMIC HANDPIECE WOULD NOT DELIVER THE POWER. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23421643 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, SHORTLY AFTER STARTING PHACOEMULSIFICATION, THE PATIENT EXPERIENCED A CORNEAL BURN IN THE LEFT EYE. THE OPHTHALMIC HANDPIECE APPEARED MILKY. SHORTLY THEREAFTER, SURGERY CONTINUED WITHOUT THE PHACOEMULSIFICATION HANDPIECE, USING A VITRECTOMY CUTTER WITH CORTICOSTEROID INSTEAD. AFTER INSERTION OF A PUPIL EXPANSION RING, VITRECTOMY WAS CONTINUED. THE CORNEA WAS SUTURED. ACETYLCHOLINE, BALANCED SALT SOLUTION, AND ANTIBIOTIC WERE APPLIED TO THE CORNEA. HUMAN AMNION WAS PLACED ON THE CORNEA, FOLLOWED BY A CONTACT LENS. MIOTICS AND ANTIBIOTIC EYE DROPS WERE ADMINISTERED. A CARBONIC ANHYDRASE INHIBITOR WAS GIVEN BY ANESTHESIOLOGY. EYE DRESSING WAS APPLIED, AND NO LENS WAS IMPLANTED. PROCEDURE DETAILS AND THE PATIENT¿S CURRENT CONDITION HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: Eye Burn

  MAUDE report 23084140 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY SYSTEM/HANDPIECE/TIP MALFUNCTIONED DUE TO WHICH PATIENT EXPERIENCED CORNEAL BURN IT LEADS TO VISION IMPACT, WOUND WAS SUTURED IN LEFT EYE. PATIENT CURRENT CONDITION WAS NOT REPORTED. NEW INFORMATION HAS BEEN RECEIVED INDICATING PATIENT LEFT EYE HAS WOUND LEAKAGE AND MANY STRIAE ARE PRESENT OF THE CORNEA CAUSING ASTIGMATISM AND OTHER ABERRATIONS. CURRENTLY VISION IS COUNTING FINGERS VISION. HE IS ALSO HAVING UVEITIS, INTRAOCULAR INFLAMMATION. CURRENT CONDITION WAS NOT KNOWN.

  Patient problems: Corneal Scar; Eye Burn; Fluid Discharge; Inflammation; Uveitis; Visual Disturbances

  MAUDE report 23074615 ↗
• MalfunctionSep 12, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHATHALMIC HANDPIECE PHACOEMULSIFICATION WAS STOPPED ON MULTIPLE OCCASIONS. THE SURGERY WAS COMPLETED WITH ALTERNATIVE HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037220 ↗
• InjuryAug 14, 2025Obstruction of Flow; Improper Flow or Infusion; Obstruction of Flow; Improper Flow or Infusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE OPHTHALMIC HANDPIECE BECAME OCCLUDED AND HAD POOR IRRIGATION, AND THE PATIENT EXPERIENCED A CORNEAL BURN AND UNDERWENT CORNEAL SUTURE AND ALSO RECEIVED CORTICOIDS AS A LOCAL TREATMENT. THE CURRENT PATIENT CONDITION WAS RESOLVED. THIS COMPLAINT IS PERTAINING THE SECOND OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Eye Burn

  MAUDE report 22806276 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A 65-YEAR MALE PATIENT ADMITTED IN HOSPITAL FOR CATARACT SURGERY DURING PROCEDURE PATIENT WAS EXPERIENCED CORNEAL BURN IN LEFT EYE AS SOON AS THE OPHTHALMIC HANDPIECE ENTERED THE EYE. THE SURGERY WAS ABORTED, AND THE PATIENT WAS HOSPITALIZED. THE PATIENT'S CURRENT CONDITION IS IMPROVING. ADDITIONAL INFORMATION RECEIVED THAT DURING SURGERY THE PATIENT HAS EXPERIENCED CORNEAL BURN AT THE INCISION SITE AND REQUIRED TWO SUTURES. THE SURGERY WAS COMPLETED NORMALLY BY REPLACING THE HANDPIECE.

  Patient problems: Eye Burn

  MAUDE report 22494960 ↗
• InjuryJul 4, 2025No Device Output; Improper Flow or Infusion; No Device Output; Improper Flow or Infusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) WAS PERFORMED IN THE RIGHT EYE OF THE PATIENT UNDER LOCOREGIONAL ANESTHESIA WITH INTRAVENOUS AND DISINFECTION OF CONJUNCTIVAL CUL-DE-SACS WITH POVIDONE-IODINE. A BLEPHAROSTAT INSTRUMENT WAS USED FOR CORNEAL PRE INCISION AND 1.8 MILLIMETER TUNNELED CORNEAL INCISION WAS DONE TO PERFORM CAPSULORHEXIS UNDER VISCOELASTIC PRODUCT. THEN A LATERAL COUNTER INCISION WAS DONE WITH THE AID OF NON ADRENALINE LOCAL ANESTHETIC AGENT IN THE ANTERIOR CHAMBER TO DO HYDRO DISSECTION AND ASPIRATION OF THE VISCOELASTIC AND PHACOEMULSIFICATION OF THE NUCLEUS WITH REDUCED IRRIGATION PRESSURE. IT WAS AT THAT TIME, THERE WAS A APPEARANCE OF A WHITISH CLOUD INDICATING OCCLUSION OF THE PHACO EMULSIFICATION TIP OF THE HANDPIECE. THE SCULPTING MODE WAS PUT ON HOLD AND THERE WAS A THERMAL RIGIDIFICATION OF THE CORNEAL EDGES. THE HANDPIECE WAS RE-PRIMED TO CONTINUE THE PHACO EMULSIFICATION WITH REMOVAL OF MASSES AND CAPSULAR POLISHING FOLLOWED BY IMPLANTATION INTO THE CAPSULAR BAG UNDER VISCOELASTIC PRODUCT. CORNEAL SUTURES WERE USED IN THE CORNEAL BURN. THE PATIENT WAS THEN PUT ON ANTIBIOTIC INJECTION WITH INJECTI

  Patient problems: Corneal Clouding/Hazing; Eye Burn; Visual Disturbances

  MAUDE report 22402808 ↗
• MalfunctionJun 2, 2025No Device Output; No Device Output

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE DID NOT WORK AND THERE WAS NO ULTRASOUND DURING PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A REPLACEMENT HANDPIECE. NO PATIENT HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121950 ↗
• InjuryMay 26, 2025Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC HANDPIECE WAS OCCLUDED. THE PATIENT EXPERIENCED THERMAL BURN AND SUTURE WAS USED FOR THE WOUND. PATIENT ALSO EXPERIENCED A REDUCED VISION DUE TO CHRONIC CORNEAL EDEMA, IMPAIRED TIGHTNESS, ASTIGMATISM DUE TO CORNEAL DEFORMATION, RISK OF ENDOTHELIAL DECOMPENSATION WITH CORNEAL OPACIFICATION, WHICH MAY BE IRREVERSIBLE. THE CURRENT OUTCOME OF THE PATIENT CONDITION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Clouding/Hazing; Corneal Edema; Corneal Endothelial Cell Loss; Eye Burn

  MAUDE report 22083321 ↗
• MalfunctionMay 17, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE WAS NOT ASPIRATING DURING CATARACT VITRECTOMY COMBINATION SURGERY. NO PATIENT IMPACT WAS REPORTED. PROCEDURE COMPLETION DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041058 ↗
• MalfunctionApr 30, 2025Decrease in Suction; Decrease in Suction

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY ON THE RIGHT EYE, SUCTION WAS WEAK IN THE OPHTHALMIC HANDPIECE WHILE IN PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933106 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED CORNEAL BURNS WHILE USING OPHTHALMIC SYSTEM AND HANDPIECE. THE OPHTHALMIC SYSTEM WAS REPLACED WITH ANOTHER ONE AND THE CORNEA WAS SUTURED. THE FURTHER DETAILS OF THE PROCEDURE AND PATIENT'S CONDITION WERE UNKNOWN. THIS REPORT PERTAINS TO OPHTHALMIC HANDPIECE INVOLVED IN THE REPORTED EVENTS.

  Patient problems: Eye Burn

  MAUDE report 21710581 ↗
• MalfunctionFeb 19, 2025No Device Output; No Device Output

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC HANDPIECE EXHIBITED NO ULTRASOUND DURING THE SURGERY IN THE QUADRANT MODE. INFORMATION REGARDING PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21408160 ↗
• MalfunctionFeb 3, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE HAD NO ULTRASOUNDS. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300669 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED CORNEAL BURN, OCCLUSION AND IRRIGATION NOT SMOOTH ENOUGH DURING PHACOEMULSIFICATION MODE OF INTRAOCULAR LENS (IOL) IMPLANTATION. THE SURGERY WAS COMPLETED AND POST SURGERY THE PATIENT EXPERIENCED ASTIGMATISM AFTER SURGERY DUE TO USING SUTURE TO CLOSE WOUND.

  Patient problems: Corneal Edema; Eye Burn

  MAUDE report 21227261 ↗