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

Model Number CUSTOM PAK

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

A pharmacist reported a phaco tip contained in a custom pak, blocked.The tip was changed.No hospitalization was needed.No pt impact reported.Additional information has been requested but not received to date.

Manufacturer Narrative

A sample is being returned.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 but not received to date.(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: 4163829
• MDR Text Key: 18032521
• Report Number: 1644019-2014-00126
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/18/2014

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 Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 391499
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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: PHACO TIP