Alcon, Kelman, TurboSonics, ABS 8065752066Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00380657520664), received between Mar 17, 2022 and Mar 30, 2026 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jun 28, 2023Class IIOpen, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2410-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP OF THE ULTRASOUND CHIP WAS BENT BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725360 ↗
• MalfunctionJan 9, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE DISTAL END OF THE US (ULTRASOUND) TIP WAS BENT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017226 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE TIP WAS BENT AT THE TIME OF OPENING BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23766501 ↗
• MalfunctionSep 17, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE ULTRASOUND TIP (PHACO EMULSIFICATION TIP) WAS TOO BENT TO USE BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT ANY PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23070677 ↗
• MalfunctionJun 26, 2025Incomplete or Inadequate Connection; Priming Problem; Incomplete or Inadequate Connection; Priming Problem

  THE PHYSICIAN REPORTED THAT PHACOEMULSIFICATION TIP (PHACO TIP) WAS LOOSE AND PRIMING TEST FAILURE OCCURRED DURING CALIBRATION. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22334669 ↗
• MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE PHACOEMULSIFICATION (PHACO) TIP WAS FOUND BENT DURING THE CALIBRATION STEP OF SURGERY. THE TYPE OF SURGERY WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22329482 ↗
• MalfunctionApr 1, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE TIP OF THE PRODUCT (PHACO EMULSIFICATION TIP) WAS FOUND BENT BEFORE SURGERY (PROCEDURE TYPE WAS UNKNOWN). THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749289 ↗
• MalfunctionDec 27, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE SHAFT WAS BENT BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21024663 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN REPORTED THAT PRODUCT COULD NOT BE ATTACHED TO A ULTRASOUND HANDPIECE DURING A TEST. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20469489 ↗
• MalfunctionAug 13, 2024Material Twisted/Bent; Material Twisted/Bent

  THE PHYSICIAN REPORTED THAT TIP WAS FOUND BENT WHEN OPENED FOR THE PREPARATION OF A HAND PIECE DURING CALIBRATION. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER TIP. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973040 ↗
• MalfunctionJul 20, 2024Suction Problem; Material Protrusion/Extrusion; Suction Problem; Material Protrusion/Extrusion

  A PHYSICIAN REPORTED THAT WHEN THE PHACO TIP WAS CHECKED DURING ULTRA SOUND, IT WAS COARSE AND ASPIRATION WAS POOR DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787072 ↗
• MalfunctionJul 20, 2024Suction Problem; Material Protrusion/Extrusion; Suction Problem; Material Protrusion/Extrusion

  A PHYSICIAN REPORTED THAT WHEN THE PHACO TIP WAS CHECKED DURING ULTRASOUND, IT WAS COARSE AND ASPIRATION WAS POOR DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787071 ↗
• MalfunctionMar 21, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP WAS BENT BEFORE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM AND PROCEDURE DETAILS WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18949524 ↗
• MalfunctionOct 11, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT THE SCREW DID NOT FIT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912319 ↗
• MalfunctionSep 17, 2023Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE MESSAGE "THERE IS A FLOW REDUCTION FAULT" WAS DISPLAYED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762246 ↗
• MalfunctionJul 28, 2023Break; Break

  A PHYSICIAN REPORTED THAT THE ULTRASOUND (US) TIP WAS BROKEN AFTER THE CATARACT SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415493 ↗
• MalfunctionJul 18, 2023Disconnection; Disconnection

  A CUSTOMER REPORTED THAT THE TIP CAME OFF EVEN AFTER TIGHTENING WHEN ATTACHING TO THE ULTRASOUND (US) HANDPIECE DURING A TEST. THE SURGERY COMPLETED WITH THE REPLACEMENT OF ANOTHER PRODUCT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342203 ↗
• MalfunctionMay 4, 2023Material Twisted/Bent; Material Twisted/Bent

  AN OPHTHALMOLOGIST REPORTED THAT THE BASE OF THE TIP WAS FOUND BENT WHEN OPENED. THE PROCEDURE WAS COMPLETED AFTER REPLACED BY ANOTHER PRODUCT. THE PROCEDURE TYPE AND PATIENT HARM DETAILS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867966 ↗
• MalfunctionFeb 20, 2023Break; Break

  A PHARMACIST REPORTED TIP OF THE PAK BROKE DURING SURGERY. THERE WAS NO SHOCK, DUE TO VIBRATIONS DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403358 ↗
• MalfunctionJan 17, 2023Break; Break

  D.3. PRODUCT MANUFACTURING SITE UPDATED DUE TO RECEIPT OF [PRODUCT INFORMATION]G.9. MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER [2523835-2023-00080]D.4. LOT NUMBER INFORMATION UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16181210 ↗
• MalfunctionAug 11, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THE PHACOEMULSIFICATION TIP WAS FOUND TO BE BENT WHEN ATTEMPTING TO TUNE AFTER SETTING THE TIP FOR A PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209408 ↗
• InjuryJul 6, 2022Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED ULTRASOUND TIP WAS CLOGGED AND THERMAL BURN OCCURRED IN THE CORNEA WITH ULTRASOUND OSCILLATION DURING A CATARACT SURGERY. THE WOUND WAS SUTURED. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THE SAMPLE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: Eye Burn

  MAUDE report 14927799 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME).

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

  MAUDE report 13867887 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH OPHTHALMIC CARTRIDGE, SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME).

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

  MAUDE report 13867597 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY PATIENT EXPERIENCED INFLAMMATION (FIBRIN) AND ENDOPHTHALMITIS. PATIENT WAS GIVEN WITH AN ANTIBACTERIAL AGENT AND THE CONDITION WAS IMPROVING. IT WAS INFORMED THAT THE PATIENT WAS IN CONTACT WITH SURGICAL PROCEDURE PACKS, VISCOELASTICS, OPHTHALMIC PHACOEMULSIFICATION TIP, OPHTHALMIC PHACOEMULSIFICATION HANDPIECE AND IRRIGATION/ASPIRATION TIP. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE SURGEON CONFIRMED THE EVENT WAS TASS (TOXIC ANTERIOR SEGMENT SYNDROME). THIS REPORT REPRESENTS PHACOEMULSIFICATION TIP INVOLVED IN THIS EVENT.

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

  MAUDE report 13867444 ↗