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

Catalog Number 8065752087

Device Problem Break (1069)

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

Event Date 03/16/2021

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 customer reported that the phaco tip broke during quadrant removal.The product was replaced and the procedure was completed.There was no patient harm.

Event Description

All available details have been provided; no additional follow-up is required at this time.

Manufacturer Narrative

The product was visually inspected and deemed nonconforming, the product was broken at the aspiration bypass (ab) hole in two pieces, slightly jagged break and even wall thickness.There was wear on the threads, nut corners and back of flange that was typical of use.The product was processed and released according to the product¿s acceptance criteria.The root cause for the product cannot be determined from this evaluation.The product visual inspection does not show any manufacturing issue that would cause the broken product.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All products are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken product exhibited on the returned opened sample, is removed from the lot and scrapped.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
• MDR Report Key: 11628902
• MDR Text Key: 244382690
• Report Number: 1644019-2021-00233
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657520879
• UDI-Public: 00380657520879
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 8065752087
• Device Lot Number: 2410483H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK