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

Model Number CUSTOM PAK

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2014

Event Type  malfunction  

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).

Event Description

A customer and a nurse reported to a company representative that a foreign material from the valved entry system was found in the eye during a vitreo retina surgery.Upon follow up it was informed that the fleck of foreign material was flushed out from the eye, absorbed by the infusion line, and saved in a syringe as a sample during the actual procedure , and is available for evaluation.

• 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: 4016877
• MDR Text Key: 19046212
• Report Number: 1644019-2014-00142
• Device Sequence Number: 1
• Product Code: CAZ
• 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,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• 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: 1578757H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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: CONSTELLATION VISION SYSTEM