MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

The materials manager reported that when the surgeon removed the cutter and the illuminator from the pt's eye during a vit-retina surgery, the items got stuck in the trocars and pulled the trocars with them.The staff obtained another trocar set and they were able to complete the surgery during the same session.No pt harm was reported.No additional info is expected.

Manufacturer Narrative

A sample has been received but has not yet been evaluated.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 info becomes available.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3576883
• MDR Text Key: 4057585
• Report Number: 1644019-2014-00001
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2013

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 Expiration Date: 04/30/2015
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1525092H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TOTAL PLUS PAK; 25+ 5.0 CPM STD