MAUDE Adverse Event Report: ALCON - BELGIUM/ALCON NV CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A pharmacist reported that a knife was noted to be blunt prior surgery.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

No sample was returned for the report of a blunt, defective knife.The final customer lot was identified as 981166m, manufactured on 09/24/2014.For this final lot, two components knife lots, manufactured in august 2014 were used to make up the final lot.A device history record review for each of the knife lots was conducted.An anomaly that could have contributed to the customer complaint was found during the device history record reviews.The device history record review does not point to a root cause because the lot was reprocessed and the product released met the manufacturer's acceptance criteria.No additional investigation is required based on device history review.A complaint history review indicates no additional complaints were associated with the knife lots.The root cause for the defect experienced by the customer cannot be determined.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Nonconformances, such as a damaged tip or cutting edge described in the complaint, are removed from the lot and scrapped.Functional testing is performed and monitored during the finishing process to ensure the sharpness of the product.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - BELGIUM/ALCON NV; medialaan 36; vilvoorde 1800 ; BE 1800
• Manufacturer (Section G): ALCON - BELGIUM/ALCON NV; medialaan 36; vilvoorde 1800 ; BE 1800
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4535555
• MDR Text Key: 5540231
• Report Number: 3002037047-2015-00046
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 408927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLEARCUT HP2 DB SLIT 2.2MM ANG