MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752202

Device Problem Material Integrity Problem (2978)

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

Event Date 10/24/2018

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 surgeon reported the a side port of the nano sleeve was bigger than usual.The procedure was performed and completed without product replacement.There was no harm to the patient.No additional information is expected.

Manufacturer Narrative

Additional information provided.The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.One 0.9 millimeter nano 30 degree ultra infusion sleeve was returned, and visually inspected.Under microscopic examination the irrigation side ports were observed to be punched twice.The irrigation holes on the infusion sleeve were properly aligned 180 degrees of each other and no damage on the irrigation center port was observed.The infusion sleeve was fitted onto an ozil handpiece (hp) and could properly fit onto the hp.No twisting or anomalies were observed.The investigation found the root cause category fell under a supplier manufacturing non-conformance.During infusion sleeve production, the supplier manufacturer double punched the irrigation holes resulting in a larger than expected irrigation hole.This observed issue would not prevent irrigation flow to the eye.Action will not be taken based on this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.The supplier has been made aware of the issue and the sample will be sent to the supplier for additional analysis.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8084606
• MDR Text Key: 128022403
• Report Number: 1644019-2018-00269
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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 Expiration Date: 10/31/2019
• Device Catalogue Number: 8065752202
• Device Lot Number: 2126495H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK