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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Corneal Ulcer (1796); Fungal Infection (2419)
Date of Event 08/11/2017
Type of Reportable Event Serious Injury
Event or Problem 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
KAMRA
Common Device Name
CORNEAL INLAY
Manufacturer (Section D)
ACUFOCUS, INC.
32 discovery
suite 200
irvine CA 92618
MDR Report Key6854103
Report Number3008401069-2017-00009
Device Sequence Number67753
Product Code LQE
UDI-Device Identifier00813359020007
UDI-Public00813359020007
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P120023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 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
Operator of Device 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
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/11/2017
Initial Report FDA Received Date09/08/2017
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 Age49 YR
-
-