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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 08/02/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The reported information stated the inlay was explanted from the right eye of a (b)(6) male patient one (1) month and 16 days postoperatively due to an epithelial ingrowth.
 
Event or Problem Description
Update: patient was reported to be improving; bcdva on (b)(6) 2016 was 20/20.
 
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Brand Name
KAMRA
Common Device Name
CORNEAL INLAY
Manufacturer (Section D)
ACUFOCUS, INC.
32 discovery
suite 200
irvine CA 92618
MDR Report Key5905510
Report Number3008401069-2016-00015
Device Sequence Number18992368
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P120023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/18/2016
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
Operator of Device Health Professional
Device Expiration Date07/27/2017
Device Model NumberACI 7000
Device Catalogue Number76043
Device Lot NumberA572-0715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2016
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 08/03/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date08/26/2016
Supplement Report FDA Received Date11/18/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age54 YR
Patient Weight125
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