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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 Visual Impairment (2138)
Date of Event 07/12/2017
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)year old male patient at the patient's request approximately 14 days postoperatively due to persistent complaints of poor near and distance vision.
 
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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 Key6790287
Report Number3008401069-2017-00008
Device Sequence Number137379
Product Code LQE
UDI-Device Identifier00813359020052
UDI-Public00813359020052
Combination Product (Y/N)Y
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
P120023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date (Section B) 10/12/2017
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 Date01/27/2018
Device Model NumberACI 7000
Device Catalogue Number76225-10
Device Lot NumberA600-0116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/13/2017
Supplement Date Received by Manufacturer09/07/2017
Initial Report FDA Received Date08/11/2017
Supplement Report FDA Received Date10/12/2017
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 Age53 YR
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