MAUDE manufacturer profile

SIE AG, SURGICAL INSTRUMENT ENGINEERING · OOE

MAUDE profile for Ophthalmic Femtosecond Laser

Key facts

Manufacturer SIE AG, SURGICAL INSTRUMENT ENGINEERING
Manufacturer group SIE AG, SURGICAL INSTRUMENT ENGINEERING
Product code OOE
Product code name Ophthalmic Femtosecond Laser

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Capsular Bag Tear, Insufficient Information, No Code Available, Appropriate Term / Code Not Available, Rupture, Corneal Perforation, No Information 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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