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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 Problems Corneal Ulcer (1796); Fungal Infection (2419)
Event Date 08/11/2017
Event Type  Injury  
Event Description
The reported information stated the inlay was explanted from the left eye of a (b)(6) male patient approximately 9 months post operatively due to a persistant corneal ulcer and suspected fungal infection over the inlay.
 
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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 Key6854103
MDR Text Key85574490
Report Number3008401069-2017-00009
Device Sequence Number1
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 09/08/2017
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 Date08/27/2017
Device Model NumberACI 7000
Device Catalogue Number76043
Device Lot NumberA580-0815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/11/2017
Initial Date FDA Received09/08/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2015
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 Age49 YR
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