MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR LAUREATE WORLD PHACO SYSTEM; PHACOFRAGMENTATION SYSTEM

Model Number LAUREATE

Device Problems Device Issue (2379); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A customer reported the footswitch was locking and there was a screen issue.Timing of the event is not known.The level of patient involvement is not known.Additional information has been requested.

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).

• Brand Name: LAUREATE WORLD PHACO SYSTEM
• Type of Device: PHACOFRAGMENTATION SYSTEM
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4524839
• MDR Text Key: 15249644
• Report Number: 2028159-2015-00211
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K021566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LAUREATE
• Device Catalogue Number: 8065750502
• Other Device ID Number: 1.05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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