Alcon, Infiniti, MicroSmooth, ABSRecalls & reported problems across all models

We found 3 models of Alcon, Infiniti, MicroSmooth, ABS by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Dec 17, 2021 and Dec 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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, Infiniti, MicroSmooth, 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.

1. 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-2408-2023 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported Alcon, Infiniti, MicroSmooth, ABS problems

Alcon, Infiniti, MicroSmooth, ABS models

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

• Alcon, Infiniti, MicroSmooth, ABS 8065750280

  Unit, phacofragmentation
  1 recall1 report
• Alcon, Infiniti, MicroSmooth, ABS 8065741085

  Unit, phacofragmentation
  1 recall0 reports
• Alcon, Infiniti, MicroSmooth, ABS 8065750281

  Unit, phacofragmentation
  1 recall0 reports

Recent Alcon, Infiniti, MicroSmooth, ABS adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2021Break; Particulates; Break; Particulates

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER WHO INDICATED THE FOREIGN MATERIAL (SIMILAR TO GLITTER) WAS NOT REMOVED DURING THE SAME PROCEDURE FROM THE PATIENT'S RIGHT EYE AS IT WAS STUCK TO THE IRIS DESPITE IRRIGATION/ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028130 ↗

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