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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORNEAGEN KAMRA INLAY
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CORNEAGEN KAMRA INLAY Back to Search Results
Model Number 76225-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Clouding/Hazing (1878); Inflammation (1932); Visual Impairment (2138)
Event Date 06/16/2018
Event Type  Injury  
Event Description
Patient requested kamra inlay be explanted due to corneal inflammation, corneal haze, and decreased vision.
 
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Brand Name
KAMRA INLAY
Type of Device
KAMRA
Manufacturer (Section D)
CORNEAGEN
101 n. chestnut st.
ste. 303
winston salem 27101
Manufacturer (Section G)
CORNEAGEN
101 n. chestnut st.
ste. 303
winston salem 27101
Manufacturer Contact
benjamin steinberg
101 n. chestnut st.
ste. 303
winston salem 27101
3365169640
MDR Report Key7718834
MDR Text Key114986892
Report Number3005357288-2018-00003
Device Sequence Number1
Product Code LQE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/27/2018
Device Model Number76225-01
Device Lot NumberA623-0616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/25/2018
Device Age2 YR
Initial Date Manufacturer Received 06/18/2018
Initial Date FDA Received07/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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