KAMRA CORNEAL INLAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for KAMRA CORNEAL INLAY manufactured by Corneagen, Inc..

MAUDE Entry Details

Report NumberMW5091314
MDR Report Key9383408
Date Received2019-11-26
Date of Report2019-11-25
Date of Event2018-11-14
Date Added to Maude2019-11-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameKAMRA CORNEAL INLAY
Generic NameIMPLANT, CORNEAL, REFRACTIVE
Product CodeLQE
Date Received2019-11-26
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCORNEAGEN, INC.

Device Sequence Number: 2

Brand NameLASIK
Generic NameEXCIMER LASER SYSTEM
Product CodeLZS
Date Received2019-11-26
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-11-26

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