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

Catalog Number 8065752917

Device Problem Break (1069)

Patient Problems Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

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 in two pieces during a procedure.The broken phaco tip was removed and procedure completed.The patient developed inflammation and requires another surgery.The exact reason for the inflammation is uncertain.

Manufacturer Narrative

One opened broken phaco tip was received.The phaco tip was visually inspected and deemed nonconforming, the phaco tip was broken at the aspiration bypass (ab) hole in two pieces, the break was jagged with even wall thickness.Wear on threads, nut corners and back of flange was typical of use.A review of the device history record traceable to the possible lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria.One photo and one video were reviewed.The photo shows a phaco tip broken in (b)(4) pieces.The reported issue of a broken/cracked phaco tip was confirmed on the photo from the customer.The video shows a phacoemulsification segment, at 1 minute and 43 seconds the broken device is observed, at 2 minutes and 50 seconds the broken device was removed.The complaint evaluation confirms the phaco tip was broken.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspection does not show any manufacturing issue that would cause the broken phaco tip.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 phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phaco tip exhibited on the returned opened sample, is removed from the lot and scrapped.No additional action is required at this time.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, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11385527
• MDR Text Key: 238392530
• Report Number: 1644019-2021-00133
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 8065752917
• Device Lot Number: 2416604H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention