Alcon, Kelman, TurboSonics, Mini-Flared 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, Mini-Flared ABS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 2 models of Alcon, Kelman, TurboSonics, Mini-Flared ABS by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2021 and Jun 16, 2026 — classified as 4 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Break” (8 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, 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, 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, Mini-Flared ABS problems
Device problems
- Break8
- Suction Problem8
- Loose or Intermittent Connection7
- Material Twisted/Bent7
- Adverse Event Without Identified Device or Use Problem4
- Complete Blockage4
- Obstruction of Flow3
- Suction Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information5
- Eye Burn4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blurred Vision1
- Endophthalmitis1
Alcon, Kelman, TurboSonics, Mini-Flared ABS models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Kelman, TurboSonics, Mini-Flared ABS 8065750852Unit, phacofragmentation1 recall21 reports
- Alcon, Kelman, TurboSonics, Mini-Flared ABS 8065750853Unit, phacofragmentation1 recall21 reports
Recent Alcon, Kelman, TurboSonics, Mini-Flared ABS adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 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 ↗
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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