ULTRA FLOW 8065751795Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380657517954), received between Mar 10, 2021 and Oct 28, 2024 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (1 report).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20550067 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542967 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542966 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542965 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540972 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540969 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540968 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540964 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540963 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540962 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540959 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20469490 ↗
• InjuryMay 3, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT A PATIENT EXPERIENCED VITREOUS LOSS AND AN OPHTHALMIC CONSOLE HAD LITTLE ASPIRATION DURING CATARACT SURGERY DUE TO WHICH THE PROCEDURE WAS ALTERED. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 19237510 ↗
• MalfunctionDec 12, 2023Decrease in Suction; Decrease in Suction

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE DID NOT REACH THE ENOUGH VACUUM TO REMOVE CORTEX. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308321 ↗
• MalfunctionJul 20, 2023Particulates; Particulates

  A CUSTOMER REPORTED THAT DURING A SURGERY, WHILE USING AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE THE PHYSICIAN HAD DISCOVERED PLASTIC OR GLASS FLOATING IN ANTERIOR CHAMBER. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEE REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359486 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER CATARACT SURGERY BY USING AN IRRIGATION/ASPIRATION (I/A) HANDPIECE AND PHACOEMULSIFICATION HANDPIECE, A PATIENT EXPERIENCED SEVERE ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WITH FUNCTIONAL LOSS OF EYE. ADDITIONAL RELATED INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE CATARACT SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT PRESENTED WITH ENDOPHTHALMITIS TWO DAYS AFTER THE SURGERY. THE PATIENT PRESENTED WITH CONJUNCTIVAL INFLAMMATION: 3+; CELLS IN THE ANTERIOR CHAMBER: 3+; FIBRIN IN THE ANTERIOR CHAMBER; AND HYPOPYON. THE PATIENT HAD PAIN, EDEMA OF THE UPPER EYELID, AND CYCLITIC MEMBRANE PREVENTING EXAMINATION OF THE VITREOUS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR SEVEN DAYS AND HAD INTRAVITREOUS INJECTION OF ANTIBIOTICS, GLUCOCORTICOID BOLUS INJECTION, INTRAVITREOUS INJECTION OF CORTICOSTEROID, STEROID IN SUB CONJUNCTIVAL FORM. THE ACTION WAS EFFECTIVE. THE PATIENT¿S VISUAL ACUITY RECOVERED TO NORMAL AND ALL THE SYMPTOMS HAVE BEEN RESOLVED. THIS IS THE THIRD OF THREE REPORTS FOR THE REPORTED EVENT FROM THIS FACILITY.

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

  MAUDE report 15437966 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER CATARACT SURGERY BY USING AN IRRIGATION/ASPIRATION (I/A) HANDPIECE AND PHACOEMULSIFICATION HANDPIECE, A PATIENT EXPERIENCED SEVERE ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL RELATED INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Conjunctivitis; Endophthalmitis; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 15201021 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER CATARACT SURGERY BY USING AN IRRIGATION/ASPIRATION (I/A) HANDPIECE AND PHACOEMULSIFICATION HANDPIECE, A PATIENT EXPERIENCED SEVERE ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL RELATED INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Conjunctivitis; Endophthalmitis; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 15176301 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AFTER CATARACT SURGERY PATIENT EXPERIENCED WITH SEVERE ENDOPHTHALMITIS OR TOXIC ANTERIOR SEGMENT SYNDROME WITH FUNCTIONAL LOSS OF EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Endophthalmitis; Eye Pain; Hypopyon; Inflammation; Loss of Vision; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 15176140 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER PERFORMING A CATARACT SURGERY, THE PATIENT EXPERIENCED POST-OPERATIVE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS CONFIRMED TO BE UNAVAILABLE FOR THIS REPORTED EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 12323369 ↗
• InjuryMar 21, 2021Material Fragmentation; Material Fragmentation

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY, A METALLIC FRAGMENT HAS BEEN DISCONNECTED AND ENTERED THE PATIENT'S EYE WHICH LEADING TO COMPLICATIONS SUCH AS CAPSULAR BAG BREAK, DISPLACEMENT OF THE VITREO FROM THE BACK SEGMENT TO THE ANTERIOR CHAMBER AND DECREASE OF INTRAOCULAR PRESSURE. NO SYSTEM MESSAGE WAS DISPLAYED. THE SURGERY WAS COMPLETED BY REMOVAL OF FRAGMENT. THE PATIENT UNDERWENT ANTERIOR VITRECTOMY WITH INTRAOCULAR LENS INSERTION IN THE CAPSULAR GROOVE, A SCLERAL CORRECT POINT WITH NYLON WAS NECESSARY.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased; Vitreous Loss

  MAUDE report 11536810 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY, THE PATIENT DEVELOPED ENDOPHTHALMITIS. PROCEDURE DETAIL INFORMATION IS UNKNOWN. THE SURGEON SUSPECTED THE HANDPIECES AS THE CAUSE OF THE EVENT, AS THERE WAS NO ISSUE AFTER REPLACING THE HANDPIECES. NO INTERVENTION WAS REQUIRED. THE PATIENT CONDITION IS STABLE.

  Patient problems: Endophthalmitis

  MAUDE report 11453055 ↗