Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA; CORNEAL INLAY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Blurred Vision (2137)
Event Date 02/22/2018
Event Type  Injury  
Event Description
The reported information stated the inlay was explanted from the left eye of a (b)(6) female patient approximately 10 months postoperatively due to blurry vision at near and distance and difficulty adapting.Prior to the explant the patient was being treated for dry eye and hyperopic shift.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7382290
MDR Text Key103861266
Report Number3008401069-2018-00001
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 Medical Assistant
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/27/2017
Device Model NumberACI 7000
Device Catalogue Number76043
Device Lot NumberA557-0515
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FS200 LASER
Patient Outcome(s) Required Intervention;
Patient Age56 YR
-
-