DR. SCHMIDT SILICONE IRIS ARTIFICIAL IRIS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-22 for DR. SCHMIDT SILICONE IRIS ARTIFICIAL IRIS * manufactured by Dr. Schmidt Intraocularlinsen, Gmbh.

Event Text Entries

[1164669] Anticipated intraocular lens dislocation, due to progressive zonulopathy and anticipated posterior capsular opacity.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011609
MDR Report Key1407114
Date Received2009-06-22
Date of Report2009-06-22
Date of Event2009-06-18
Date Added to Maude2009-07-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDR. SCHMIDT SILICONE IRIS
Generic NameIRIS PROSTHETIC DEVICE
Product CodeNCK
Date Received2009-06-22
Model NumberARTIFICIAL IRIS
Catalog Number*
Lot Number133028-918
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerDR. SCHMIDT INTRAOCULARLINSEN, GMBH
Manufacturer Address* ST. AUGUSTIN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2009-06-22

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