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

Model Number CUSTOM PAK

Device Problems Fitting Problem (2183); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

An ophthalmic surgeon reported that foreign material was found on the tip of the light guide during a vitrectomy procedure.On initial usage the surgeon reported difficulty with inserting and removing the light guide.The product was replaced with another one and the surgery was completed without any consequence to the patient.Additional information has been requested.

Manufacturer Narrative

A product sample was 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: 4402008
• MDR Text Key: 21245228
• Report Number: 1644019-2015-00001
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 1656085H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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: CONSTELLATION VISION SYSTEM; STANDARD; TOTAL PLUS PAK, 5000 CUTS PER MINUTE, VALVED