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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 Corneal Edema (1791)
Date of Event 06/21/2017
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
CORNEAL INLAY
Manufacturer (Section D)
ACUFOCUS, INC.
32 discovery
suite 200
irvine CA 92618
MDR Report Key6777136
Report Number3008401069-2017-00007
Device Sequence Number1604728
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (Y/N)N
PMA/510(K) Number
P120023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/09/2017
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 NumberA574-0715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2017
Initial Report FDA Received Date08/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
AMO IFS - POCKET CUTTING FOR KAMRA IMPLANTATION
Outcome Attributed to Adverse Event Required Intervention;
Patient Age61 YR
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