Alcon, Ozil, TurboSonics, Mini-Flared ABSRecalls & reported problems across all models
Alcon Laboratories, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Alcon, Ozil, TurboSonics, Mini-Flared ABS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Alcon, Ozil, TurboSonics, Mini-Flared ABS by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2021 and Jun 20, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (6 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Alcon, Ozil, TurboSonics, Mini-Flared ABS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported Alcon, Ozil, TurboSonics, Mini-Flared ABS problems
Device problems
- Suction Failure6
- Material Twisted/Bent3
- Obstruction of Flow3
- Loose or Intermittent Connection2
- Appropriate Device Problem Term/Code Not Available1
- Decrease in Suction1
- Inability to Irrigate1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information2
Alcon, Ozil, TurboSonics, Mini-Flared ABS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Ozil, TurboSonics, Mini-Flared ABS 8065751176Unit, phacofragmentation1 recall12 reports
- Alcon, Ozil, TurboSonics, Mini-Flared ABS 8065751178Unit, phacofragmentation1 recall2 reports
- Alcon, Ozil, TurboSonics, Mini-Flared ABS 8065751177Unit, phacofragmentation1 recall0 reports
Recent Alcon, Ozil, TurboSonics, Mini-Flared ABS adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025Obstruction of Flow; Obstruction of Flow
A CUSTOMER REPORTED THAT THE ULTRASOUND DID NOT WORK, EVEN THOUGH THE TESTS WERE PASSING DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAIL WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 22301454 ↗MalfunctionJun 13, 2025Obstruction of Flow; Obstruction of Flow
A PHARMACIST REPORTED THAT THE ULTRASOUND STOPPED WORKING DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PHACOEMULSIFICATION TIP WITH NEW ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE PHACOEMULSIFICATION TIP INVOLVED IN THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201740 ↗MalfunctionNov 22, 2024Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT THE TIP OF A PRODUCT WAS FOUND BENT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20755694 ↗MalfunctionJul 3, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED ASPIRATION FAILURE OF THE PHACO TIP OCCURRED DURING ULTRA SOUND OF SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19664087 ↗MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT THE SHAPE WAS DEFECTIVE AND A BEVEL WAS MISSING BEFORE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Insufficient Information
MAUDE report 19603743 ↗MalfunctionJul 3, 2023Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED TIP WAS FOUND TO BE BENT FROM THE BEGINNING DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17247873 ↗MalfunctionJun 6, 2023Decrease in Suction; Inability to Irrigate; Decrease in Suction; Inability to Irrigate
A PHYSICIAN REPORTED THAT ASPIRATION AND IRRIGATION WAS NOT ADEQUATE AND DID NOT IMPROVE DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070024 ↗MalfunctionNov 4, 2022Loose or Intermittent Connection; Suction Failure; Loose or Intermittent Connection; Suction Failure
A PHYSICIAN REPORTED A US (ULTRASOUND) OSCILLATION FAILURE OCCURRED DUE TO LOOSENING DESPITE TIGHTENING US TIP DURING A SURGERY. THE SURGERY TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15727017 ↗MalfunctionOct 6, 2022Loose or Intermittent Connection; Suction Failure; Loose or Intermittent Connection; Suction Failure
A PHYSICIAN REPORTED TIP BECAME LOOSE, AND ULTRASOUND (US) OSCILLATION WAS UNABLE TO BE PERFORMED DURING ULTRASOUND PHASE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551389 ↗MalfunctionMay 27, 2022Suction Failure; Suction Failure
A PHYSICIAN REPORTED ASPIRATION WAS POOR DURING ULTRASOUND PHASE OF A CATARACT SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14521845 ↗MalfunctionMay 7, 2022Particulates; Particulates
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY METALLIC POWDER-LIKE SUBSTANCE WAS LEFT ON THE IRIS DURING SURGERY. SURGEON SUSPECT FOREIGN OBJECT WAS FROM THE PHACOEMULSIFICATION HANDPIECE, PHACO TIP, SLEEVE, OR PACK. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE FOREIGN MATERIAL AND THE PATIENT IS SCHEDULED FOR OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14318016 ↗MalfunctionMay 28, 2021Suction Failure; Suction Failure
A PHYSICIAN REPORTED AN ASPIRATION FAILURE OCCURRED DURING THE ULTRASOUND (US) PHASE OF A CATARACT PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11899834 ↗MalfunctionApr 16, 2021Suction Failure; Suction Failure
A CUSTOMER REPORTED THAT THE ULTRASOUND TIP WAS CLOGGED AND ASPIRATION FAILURE OCCURRED. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE IS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11682177 ↗MalfunctionApr 2, 2021Appropriate Device Problem Term/Code Not Available; Suction Failure; Appropriate Device Problem Term/Code Not Available; Suction Failure
A SURGEON REPORTED WHEN USING THE HANDPIECE DURING THE ULTRASOUND PHASE OF A CATARACT PROCEDURE, THE OSCILLATION AND ASPIRATION STOPPED ACTUATING. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER REPLACING THE ULTRASOUND TIP. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11609381 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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