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

Catalog Number 8065000134TL

Device Problems Break (1069); Suction Problem (2170)

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

Event Date 05/04/2021

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 phaco tip was broken while in the patients eye during cataract procedure.Aspiration was poor.The broken tip were removed.The procedure was completed with a new tip.There was no patient harm.

Manufacturer Narrative

One opened phacoemulsification (phaco) tip in a box was received.The phacoemulsification tip was visually inspected and deemed nonconforming, the phaco tip was broken across the air bypass (ab) hole with a jagged edge.The phaco tip had even wall thickness.There was wear on the threads, back of the flange and on the nut corners that was consistent with use.There was no occlusion observed in the inner diameter (id) of both pieces of the broken phaco tip returned.A functional flow check for occlusion was performed and deemed conforming.A good flow exiting the phaco tip was observed.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.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.The complaint evaluation does not confirm the report of the phaco tip aspiration failure.The returned sample was found to be conforming for all visual and functional testing associated with the reported event of occlusion.No action was taken for the report of poor aspiration as the sample was functionally conforming.The exact root cause for the reported issue of broken or cracked phaco cannot be determined from this evaluation, therefore, no specific action with regard to this complaint was taken.All phaco 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: 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: 11776951
• MDR Text Key: 249436024
• Report Number: 1644019-2021-00306
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065000134TL
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Age: 78 YR