Alcon, Kelman, TurboSonics, ABSRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Alcon, Kelman, TurboSonics, ABS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 2 models of Alcon, Kelman, TurboSonics, ABS by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2022 and Jul 9, 2026 — classified as 7 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (17 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, Kelman, TurboSonics, 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, 2023Open, 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 2 of these models · Recall details · FDA record ↗
Most reported Alcon, Kelman, TurboSonics, ABS problems
Device problems
- Material Twisted/Bent17
- Adverse Event Without Identified Device or Use Problem6
- Break3
- Obstruction of Flow3
- Complete Blockage2
- Incomplete or Inadequate Connection2
- Material Protrusion/Extrusion2
- Suction Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Toxic Anterior Segment Syndrome (TASS)5
- Uveitis5
- Eye Burn2
- Blurred Vision1
- Corneal Ulcer1
Alcon, Kelman, TurboSonics, ABS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Kelman, TurboSonics, ABS 8065752066Unit, phacofragmentation1 recall28 reports
- Alcon, Kelman, TurboSonics, ABS 8065752065Unit, phacofragmentation1 recall9 reports
Recent Alcon, Kelman, TurboSonics, ABS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 25758887 ↗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 25, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT THE CENTRAL PORTION OF THE TIP WAS CURVED AND CAN BE SEEN EVEN IF IT WAS NOT OPEN BEFORE SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23892327 ↗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 ↗MalfunctionDec 5, 2025Obstruction of Flow; Incomplete or Inadequate Connection; Obstruction of Flow; Incomplete or Inadequate Connection
A PHYSICIAN REPORTED THAT THERE WAS NO ULTRASOUND DURING ULTRASOUND MODE OF CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP.
Patient problems: Insufficient Information
MAUDE report 23725346 ↗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 ↗MalfunctionJun 16, 2025Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED THAT ASPIRATION STOPPED WORKING IN THE MIDDLE OF THE PROCESS DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212933 ↗MalfunctionJun 6, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT A PHACOEMULSIFICATION (PHACO) TIP WAS BENT DURING THE CALIBRATION STEP OF SURGERY. THE SURGERY AND PATIENT DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY WAS COMPLETED BY REPLACING THE NEW PACK FOR THE BALANCED TIP. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157613 ↗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 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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