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

Model Number INFINITI OZIL

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Difficult or Delayed Activation (2577); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

A customer reported that during a procedure, the footswitch was freezing intermittently.The case was completed using an alternate footswitch.There was no patient harm.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).This report was mailed to fda on: 06/20/2014.(b)(4).

• Brand Name: INFINITI VISION SYSTEM OZIL
• Type of Device: PHACOFRAGMENTATION SYSTEM
• 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: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3964404
• MDR Text Key: 4606043
• Report Number: 2028159-2014-01158
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K082845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFINITI OZIL
• Device Catalogue Number: 8065750833
• Other Device ID Number: 2.06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INFINITI ENHANCED FOOTSWITCH