MAUDE manufacturer profile

ALCON LENSX, INC. · OOE

MAUDE profile for Ophthalmic Femtosecond Laser

Key facts

Manufacturer ALCON LENSX, INC.
Manufacturer group ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Product code OOE
Product code name Ophthalmic Femtosecond Laser

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Insufficient Information, Capsular Bag Tear, No Code Available, Failure to Align Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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