• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

ALCON - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM Back to Search Results
Model Number INFINITI
Device Problems Device operational issue; Infusion or flow issue
Event Date 01/08/2013
Event Type  Malfunction  
Event Description

A surgeon reported that during a procedure irrigation would not stop even though the footswitch was not being controlled. An alternate pack was used to complete the case. There was no harm to the pt.

 
Manufacturer Narrative

The customer did not retain a sample for this complaint report; functional testing could not be conducted. The customer's complaint history was reviewed for the period of one year; this is the first complaint reported for this issue. This is the (b)(4) complaint for the finish goods lot; however, the first for this issue. The order was built and released per specification. The root cause could not be determined. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFINITI VISION SYSTEM
Type of DevicePHACOFRAGMENTATION SYSTEM
Manufacturer (Section F)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
terry dagnon
6201 south freeway
r7-18
fort worth , TX 76134
(817) 551 -4325
Device Event Key2995368
MDR Report Key2945178
Event Key2841694
Report Number2028159-2013-00134
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberINFINITI
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/22/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/31/2013 Patient Sequence Number: 1
Treatment
INTREPID PACK 0.9MM
-
-