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

Model Number CUSTOM PAK

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The surgeon reported to an account manager that some of the pink ultra phacoemulsification sleeves have been of variable quality.Some of the phacoemulsification sleeves do not slide easily through the 2.2 incision and tend to bulge around the sleeve just outside the incision as he pushed the phacoemulsification tip further into anterior chamber during cataract surgery.No pt harm reported.No add'l info is expected.

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 add'l reportable info becomes available.(b)(4).

• Brand Name: CUSTOK 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: 3815628
• MDR Text Key: 4398531
• Report Number: 1644019-2014-00054
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• 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: CUSTOME PAK
• Device Lot Number: 1505349H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: ASSY, SHIP, KIT 0.9MM ULTRA