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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 Visual Impairment (2138)
Event Date 07/12/2017
Event Type  Injury  
Event 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
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 Key6790287
MDR Text Key82559680
Report Number3008401069-2017-00008
Device Sequence Number1
Product Code LQE
UDI-Device Identifier00813359020052
UDI-Public00813359020052
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P120023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date 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
Device Operator 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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2017
Initial Date FDA Received08/11/2017
Supplement Dates Manufacturer Received09/07/2017
Supplement Dates FDA Received10/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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