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

Model Number INFINITI OZIL

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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).

Event Description

A customer reported foot pedal issues prior to surgery.There was no patient involvement.Additional information has been requested.

• 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: 4523676
• MDR Text Key: 21852155
• Report Number: 2028159-2015-00177
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• 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
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2006
• 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