Alcon, Kelman, TurboSonics, Mini-Flared ABS 8065750852Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380657508525), received between Apr 22, 2021 and Jun 16, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE ULTRASONIC (US) TIP WAS FOUND TO BE BENT UPON OPENED BEFORE SURGERY. THE PROCEDURE TYPE AND PROCEDURE COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514582 ↗
• MalfunctionAug 8, 2025Complete Blockage; Complete Blockage

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT PHACOEMULSIFICATION TIP WAS CLOGGED AT AN UNKNOWN TIMING. PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED THAT EVENT OCCURRED DURING CATARACT SURGERY WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747200 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT CORNEAL BURN WAS OCCURRED DURING INTRODUCING PHACOEMULSIFICATION TIP INTO THE INCISION OF THE LEFT EYE CONJUNCTION, RESULTED IN THE SUTURES WERE REQUIRED TO APPLY SCLERA PATCHES TO THE AREA WITH BURN INJURY TWICE. ALSO, PATIENT EXPERIENCED A NARROW CHAMBER AND DECREASE OF VISION IN LEFT EYE. THE PROCEDURE WAS CONCLUDED WITH SUTURE IN CORNEAL BURN AREA AND INTRAOCULAR LENS IMPLANTATION. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE PATIENT UNDERWENT THESE TWO NEW SURGERIES ON TWO OCCASIONS TO SEAL THE WOUND COMPLETELY. SYMPTOMS OF PATIENT CONDITION WAS CONTINUING AT THE TIME OF SURGERY. CURRENT PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Blurred Vision; Eye Burn

  MAUDE report 18839633 ↗
• MalfunctionJan 17, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT LOOSE TIP WAS OBSERVED. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE EVENT WAS OCCURRED DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523907 ↗
• MalfunctionJan 9, 2023Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THE NEEDLE WAS BENT BEFORE A VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119853 ↗
• MalfunctionOct 11, 2022Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED TIP CLOGGING OCCURRED DURING A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM. THE SAMPLE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576669 ↗
• MalfunctionJun 29, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED TIP OF TIP WAS FOUND TO BE BENT WHEN OPENED BEFORE A VITRECTOMY PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851059 ↗
• MalfunctionJan 17, 2022Noise, Audible; Noise, Audible

  A PHYSICIAN REPORTED AN OCCLUSION SOUND WAS HEARD DURING THE CATARACT PROCEDURE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265490 ↗
• MalfunctionJan 17, 2022Complete Blockage; Particulates; Complete Blockage; Particulates

  A PHYSICIAN REPORTED TIP OF THE PHACOEMULSIFICATION GETS BLOCKED, WITHOUT ASPIRATION AND THERE ARE FRAGMENTS DURING A CATARACT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265488 ↗
• MalfunctionJan 13, 2022Complete Blockage; Suction Failure; Complete Blockage; Suction Failure

  A CUSTOMER REPORTED AN ASPIRATION ISSUE DURING A SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE IS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REP WHO INDICATED ASPIRATION WAS ABSENT AND OCCLUSION SOUND WAS CONTINUOUSLY HEARD DURING THE CATARACT PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13250695 ↗
• MalfunctionJul 7, 2021Suction Failure; Suction Failure

  A PHARMACIST REPORTED PHACOEMULSIFICATION TIP DID NOT HAVE SUCTION DURING A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127856 ↗
• MalfunctionJun 8, 2021Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THE PHACOEMULSIFICATION (PHACO) TIP DID NOT ASPIRATE, LIKE THERE WAS A CLOG IN THE TIP, WHILE USING ULTRASOUND (US) POWER DURING A LEFT EYE CATARACT PROCEDURE. THE WOUND BECAME WHITE LIKE A BURN. AFTER THE OPERATION, THE STAFF WITNESSED A WHITE OBJECT PASSING THROUGH THE ASPIRATION LINE AND THE PHYSICIAN SUSPECTED THE PREVIOUS FOREIGN MATERIAL (RESIDUAL NUCLEUS) MAY HAVE REMAINED IN THE TIP SINCE THE TIP WAS REUSED. THE SURGEON INDICATED THE PATIENTS OUTCOME WAS IMPROVING.

  Patient problems: Eye Burn

  MAUDE report 11959408 ↗
• MalfunctionMay 12, 2021Suction Problem; Suction Problem

  A PHYSICIAN REPORTED EXPERIENCING ASPIRATION ISSUES AS THE PHACOEMULSIFICATION TIPS ARE MORE PRONE TO CLOGGING ON DENSE CATARACTS DURING AN UNKNOWN NUMBER OF CATARACT PROCEDURES. IT IS UNKNOWN IF THE PROCEDURES WERE COMPLETED AND THE OUTCOME OF THE PATIENTS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814352 ↗
• MalfunctionMay 12, 2021Suction Problem; Suction Problem

  A PHYSICIAN REPORTED EXPERIENCING ASPIRATION ISSUES AS THE PHACOEMULSIFICATION TIPS ARE MORE PRONE TO CLOGGING ON DENSE CATARACTS DURING AN UNKNOWN NUMBER OF CATARACT PROCEDURES. IT IS UNKNOWN IF THE PROCEDURES WERE COMPLETED AND THE OUTCOME OF THE PATIENTS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814327 ↗
• MalfunctionMay 7, 2021Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT DURING QUARTERS OF A CATARACT EXTRACTION PROCEDURE THERE WAS A PROBLEM WITH ASPIRATION. THE SURGEON HAS NOTED THIS SEEMS TO COINCIDE WITH THE SUBSTITUTION OF THE PHACO TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790794 ↗
• MalfunctionMay 5, 2021Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT DURING QUARTERS OF A CATARACT EXTRACTION PROCEDURE THERE WAS A PROBLEM WITH ASPIRATION. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778654 ↗
• MalfunctionMay 4, 2021Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT DURING THE "QUARTERS" PHASE OF A CATARACT EXTRACTION PROCEDURE THERE WAS NO ASPIRATION. THE HANDPIECE AND THE TIP WERE IMMERSED IN A CUP OF SOLUTION BUT THE ISSUE WAS NOT RESOLVED. ASPIRATION WORKED PERFECTLY IN THE IRRIGATION/ASPIRATION MODE. SURGERY TIME WAS LENGTHENED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE HANDPIECE WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769863 ↗
• MalfunctionMay 4, 2021Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT DURING THE "QUARTERS" PHASE OF A CATARACT EXTRACTION PROCEDURE THERE WAS AN ISSUE WITH ASPIRATION. ASPIRATION WORKED PERFECTLY IN THE IRRIGATION/ASPIRATION MODE. SURGERY TIME WAS LENGTHENED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE HANDPIECE WITH NO HARM TO THE PATIENT. SURGERY TIME WAS LENGTHENED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769665 ↗
• MalfunctionApr 30, 2021Suction Problem; Suction Problem

  A CUSTOMER REPORTED EXPERIENCING ASPIRATION PROBLEMS DURING QUARTERS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 11753683 ↗
• MalfunctionApr 23, 2021Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT DURING "QUARTERS" OF A CATARACT EXTRACTION PROCEDURE THERE WAS A PROBLEM WITH ASPIRATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716552 ↗
• MalfunctionApr 22, 2021Suction Problem; Suction Problem

  THE SURGERY WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706319 ↗