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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA; CORNEAL INLAY
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ACUFOCUS, INC. KAMRA; CORNEAL INLAY Back to Search Results
Model Number ACI 7000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Corneal Edema (1791)
Event Date 06/21/2017
Event Type  Injury  
Event Description
The reported information stated the inlay was explanted from the left eye of a (b)(6) male patient approximately eight (8) months postoperatively due to an inflammatory reaction on the inlay interface with decreased visual acuity, increased ocular scatter, and prescription.
 
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Brand Name
KAMRA
Type of Device
CORNEAL INLAY
Manufacturer (Section D)
ACUFOCUS, INC.
32 discovery
suite 200
irvine CA 92618
Manufacturer Contact
sandra selvaggi
32 discovery
suite 200
irvine, CA 92618
9495859511
MDR Report Key6777136
MDR Text Key82154749
Report Number3008401069-2017-00007
Device Sequence Number1
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (y/n)N
PMA/PMN Number
P120023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/27/2017
Device Model NumberACI 7000
Device Catalogue Number76043
Device Lot NumberA574-0715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AMO IFS - POCKET CUTTING FOR KAMRA IMPLANTATION
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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