Alcon, Kelman, TurboSonics, Mini-Flared ABS 8065750853Recalls & reported problems
Alcon Laboratories, Inc. · 45° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip · Class 2
All models of Alcon, Kelman, TurboSonics, Mini-Flared ABS (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380657508532), received between May 5, 2021 and Mar 18, 2026 — classified as 3 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Break8
- Loose or Intermittent Connection6
- Material Twisted/Bent4
- Adverse Event Without Identified Device or Use Problem3
- Blocked Connection2
- Obstruction of Flow2
- Defective Device1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information4
- Eye Burn2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Endophthalmitis1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Defective Device; Material Twisted/Bent
A NURSE REPORTED THAT WHEN PLACING THE PHACOEMULSIFICATION NEEDLE ON THE TABLE, IT WAS OBSERVED THAT IT WAS TOO SHORT AND BADLY CURVED (BENT TIP) BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624727 ↗MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT TIP WAS BENT DURING SURGERY. PATIENT IMPACT, SURGERY AND PROCEDURE DETAILS WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23529476 ↗MalfunctionSep 19, 2025Break; Break
A NURSE REPORTED PHACOEMULSIFICATION TIPS BROKE INSIDE THE PATIENT'S EYE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23098460 ↗MalfunctionSep 17, 2025Break; Break
A NURSE REPORTED THAT PHACOEMULSIFICATION (PHACO) TIP BROKEN AND FELL DOWN IN PATIENTS¿ EYE DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY DETAILS AND PATIENT DETAILS WERE UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23070678 ↗MalfunctionApr 21, 2025Break; Break
A NURSE REPORTED THAT THE PHACOEMULSIFICATION TIP BROKEN INSIDE THE PATIENT'S EYE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE BROKEN TIP. THERE WAS A CONTACT WITH THE PATIENT WITH NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870968 ↗MalfunctionApr 18, 2025Break; Break
A NURSE REPORTED TIP BROKEN INSIDE THE PATIENT¿S EYE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE BROKEN TIP. THERE WAS A CONTACT WITH THE PATIENT BUT NO IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21866076 ↗MalfunctionMar 2, 2025Break; Break
A NURSE REPORTED TIP WAS BROKEN INSIDE PATIENT¿S EYE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REMOVAL OF TIP. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED AND SPECIFIED THAT TIP WAS REUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501119 ↗MalfunctionDec 3, 2024Break; Break
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT PHACOEMULSIFICATION TIP BROKEN DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT OF A HARD CATARACT. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 20829381 ↗MalfunctionMar 14, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT THE ADVISORY CODE DISPLAYED (LOOSE TIP) DURING CALIBRATION, THE PROCEDURE DETAILS WAS UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18901408 ↗MalfunctionMar 5, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT DURING CALIBRATION THE ADVISORY CODE DISPLAYED (LOOSE TIP), THE PROCEDURE DETAILS WAS UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18843032 ↗MalfunctionJan 11, 2024Break; Loose or Intermittent Connection; Blocked Connection; Break; Loose or Intermittent Connection; Blocked Connection
AN OTHER HEALTH PROFESSIONAL REPORTED UNABLE TO RETRIEVE PHACO HANDPIECE TIP NEEDLE FROM PHACOEMULSIFICATION HANDPIECE. TIP GETS JAMMED AND SOMETIMES BROKE IN RETRIEVAL PROCESS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490505 ↗InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT DURING A CATARACT SURGERY A PATIENT EXPERIENCED CORNEAL BURN AND THE WOUND WAS STITCHED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THE PATIENT CONDITION IS STABLE. THIS IS ONE OF THREE REPORTS FOR THIS ISSUE AND REPRESENTS THE PHACOEMULSIFICATION HANDPIECE.
Patient problems: Eye Burn
MAUDE report 18109034 ↗MalfunctionSep 20, 2023Break; Blocked Connection; Break; Blocked Connection
A PHYSICIAN REPORTED THAT THE TIP WAS BROKEN AND THE HANDPIECE DID NOT ASPIRATE AND IRRIGATE CORRECTLY AT AN UNKNOWN TIMING. THE PROCEDURE WAS COMPLETED AFTER THE TIP WAS CHANGED. THE PATIENT HARM DETAILS WAS NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17782042 ↗MalfunctionSep 6, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A NURSE REPORTED THAT PRODUCT CANNOT BE TIGHTENED TIGHTLY BEFORE SURGERY. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689420 ↗MalfunctionAug 25, 2023Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent
A NURSE REPORTED THAT THE TIP OF NEEDLE CURVED DURING CATARACT SURGERY AND ERROR MESSAGE OF "FLOW OBSTRUCTION¿ WAS DISPLAYED WHEN EQUIPMENT WAS CONNECTED. 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 17622939 ↗MalfunctionMay 2, 2023Disconnection; Disconnection
A NURSE REPORTED NEEDLES LOOSENED ON THE PHACOEMULSIFICATION HANDPIECE DURING SURGERY. HOWEVER, EXTRA TIGHTENING WAS DONE PRIOR TO SURGERY. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16856568 ↗MalfunctionApr 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A NURSE REPORTED NEEDLES LOOSENED ON THE PHACOEMULSIFICATION HANDPIECE DURING SURGERY. HOWEVER, EXTRA TIGHTENING WAS DONE PRIOR TO SURGERY. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823124 ↗MalfunctionApr 26, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A NURSE REPORTED THAT THE NEEDLES LOOSENING ON THE PHACO HAND PIECE DURING THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817419 ↗MalfunctionAug 3, 2022Material Twisted/Bent; Material Twisted/Bent
A CUSTOMER REPORTED SOME PHACOEMULSIFICATION TIPS WERE FOUND TO BE BENT DURING THE SET UP FOR A PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15155026 ↗InjurySep 15, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
NEW INFORMATION WAS RECEIVED WHICH HAS INDICATED THAT IT WAS NOT CONFIRMED THERE WAS NOT AN OCCLUSION IN THE PHACO TIP. THE CAUSE OF THE BURN WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Burn
MAUDE report 12476492 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED ENDOPHTHALMITIS WHICH APPEARED IN SEVERAL PATIENTS WITHOUT KNOWN ROOT CAUSE.
Patient problems: Endophthalmitis
MAUDE report 11776000 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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