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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
Device Problem Insufficient Information (3190)
Patient Problem Impaired Healing (2378)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Mdr was initially sent via cd.Cd was rejected and returned to corneagen.We became aware of this earlier today ((b)(6) 2018).Submitting via emdr now.[(b)(4)].
 
Event Description
Kamra inlay was explanted from patient due to reported induced astigmatism caused by epithelial ingrowth.
 
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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 Key7724395
MDR Text Key115188764
Report Number3005357288-2018-00002
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
Remedial Action Inspection
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2020
Device Model Number76225
Device Lot NumberA635-0317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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