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: I-OPTICS BV CASSINI; CORNEAL TOPOGRAPHER SYSTEM
  • 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
 

I-OPTICS BV CASSINI; CORNEAL TOPOGRAPHER SYSTEM Back to Search Results
Lot Number SOFTWARE V2.0.0
Device Problems Application Program Version or Upgrade Problem (2881); Data Problem (3196); Patient Data Problem (3197)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/17/2014
Event Type  malfunction  
Event Description
After upgrading the cassini software at a customer by an i-optics' representative, a new patient was scanned.The i-optics employee discovered that this patient examination data was linked to another (previously) scanned patient.All other patient records were checked by the customer and i-optics employee to confirm no charts would be affected.No pt data was used for diagnosis or therapeutic treatment between the update and record integrity check.No pts were affected.The issue was immediately reported to i-optics bv.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CASSINI
Type of Device
CORNEAL TOPOGRAPHER SYSTEM
Manufacturer (Section D)
I-OPTICS BV
mauritskade 35
the haque 35251 4 HD
NL  352514 HD
Manufacturer Contact
l heller, manager
mauritskade 35
the haque 00002-514
NL   00002514
03993112
MDR Report Key4322193
MDR Text Key5132842
Report Number3008251789-2014-00001
Device Sequence Number1
Product Code MMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPTED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Remedial Action Inspection
Type of Report Initial
Report Date 11/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberSOFTWARE V2.0.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/17/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-