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

Catalog Number ASKU

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported it was not possible to screw the phaco tip to the phaco probe handpiece before a surgery.The procedure was completed.There was no patient contact with the device.The reported cannot be followed for further information.

Manufacturer Narrative

One opened phacoemulsification tip with wrench in a bag were received for the report of it was not possible to screw the phacoemulsification tip to the phacoemulsification probe ozil.The phacoemulsification tip was visually inspected and found non-conforming, there was rolled over metal on the threads.The threads were checked with a go/no-go 4-40 thread gage and the threads were deemed to be nonconforming.There was wear on the threads consistent with threading on a handpiece.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The complaint evaluation confirms that the tip would not be able to be threaded on a handpiece due to the threads were damaged.Since the product was returned opened, how and when the phacoemulsification threads became damaged cannot be determined from this evaluation and the root cause cannot be determined.The exact root cause for the report of not being able to screw the phacoemulsification tip to the phacoemulsification handpiece is unknown; therefore specific action with regards to this complaint cannot be taken.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15493297
• MDR Text Key: 301575127
• Report Number: 1644019-2022-00773
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFINITI VISION SYSTEM, HANDPIECE TIP