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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 No Apparent Adverse Event (3189)
Health Effect - Clinical Code Keratitis (1944)
Date of Event 12/05/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient's eye.
 
Event or Problem Description
Patient had a kamra inlay implantation and prk (photorefractive keratectomy) procedure on the right eye.One (1) day postoperatively it was reported that the patient had stage 2 dlk (diffuse lamellar keratitis).On (b)(6) 2016, the patient was seen for a second opinion and was diagnosed with stage 4 dlk.Patient was treated with topical and oral prednisolone for four (4) months.
 
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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 Key5568781
Report Number3008401069-2016-00006
Device Sequence Number517747
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P120023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/21/2016
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 Date03/27/2017
Device Model NumberACI 7000
Device Catalogue Number76043
Device Lot NumberA545-0315
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 03/16/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date04/11/2016
Supplement Report FDA Received Date07/21/2016
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 Age51 YR
Patient Weight91
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