Alcon, Kelman, TurboSonics, Tapered ABS, MicroTipRecalls & reported problems across all models

We found 2 models of Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2022 and Oct 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Flow” (1 report).

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

Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip 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.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip problems

Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip 8065750263

  Unit, phacofragmentation
  1 recall2 reports
• Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip 8065750264

  Unit, phacofragmentation
  1 recall0 reports

Recent Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023No Flow; No Flow

  A PHYSICIAN REPORTED THAT ASPIRATION IN THE PHACO PROGRAM NO LONGER WORKED AND PHACO TIP CONSTIPATION WAS SUSPECTED DURING THE CATARACT [WITH INTRAOCULAR (IOL) IMPLANT] SURGERY. THE SURGERY COULD BE COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850104 ↗
• MalfunctionSep 19, 2022Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT STOPPED OSCILLATING IN THE MIDDLE OF ULTRASOUND PHASE, AND OSCILLATION FAILURE WAS CONFIRMED DURING CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444297 ↗

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