MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; PHACOFRAGMENTATIONN SYSTEM

Catalog Number 8065751763

Device Problem Increase in Suction (1604)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/31/2014

Event Type  Injury  

Event Description

A surgeon reported that a surge in vacuum occurred during surgery causing a posterior capsule tear.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.Additional information has been requested.(b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: PHACOFRAGMENTATIONN SYSTEM
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY PARK; 15800 alton pkwy.; irvine CA 92618 381
• Manufacturer Contact: janet moran ; r3-48; fort worth, TX 92618-3818 ; 8176152742
• MDR Report Key: 3830088
• MDR Text Key: 17384075
• Report Number: 2028159-2014-00752
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Other Device ID Number: 02.01_BD_0042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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
• Patient Outcome(s): Other