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

Model Number CUSTOM PAK

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

An ophthalmic surgeon reported that vitreous humor leaked from the trocar cannula during a vitrectomy procedure.The surgery was completed after replacing the trocar cannula with another one.There was no report of harm to the patient.Additional information has been requested.

Manufacturer Narrative

A product sample has been requested; however, it has not yet been received by the manufacturer.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: 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: 4426372
• MDR Text Key: 5374037
• Report Number: 1644019-2015-00003
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1572480H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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, 23 GAUGE, 5000 CUTS PER MINUTE,; VALVED, STANDARD