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

Catalog Number 8065752105

Device Problem Pressure Problem (3012)

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

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 aspiration pressure did not rise during phacoemulsification.It improved after replacing the product with another one and the surgery was completed.There was no patient harm.

Manufacturer Narrative

Additional information provided in d.10, h.3, h.6 and h.10.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 wet fluidics management system (fms) was visually inspected.The fms was then functionally tested.The sample failed to prime and generated a system message code 164.Less fluid flowed from the balanced salt solution (bss) bottle to the cassette.The drip chamber was cut off and connected the one from the lab stock to the administration line.The sample passed priming and tuning with the ultrasonic handpiece.Max vacuum could reach to 710 mmhg.No message code, no fluid or air leaks, and no cracks on the luers were found.The irrigation and aspiration flow rates were within specification.Fluid flowed from the bss bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion was found in all manifolds.The returned drip chamber was then connected back to the sample to check for priming and fluid flow.The same failure mode occurred.The detected drip chamber prevented fluid to flow to the cassette, thus the sample failed to prime.The root cause of the customer¿s complaint is believed to be an error that occurred during the supplier¿s manufacturing process.The supplier will be made aware of the issue; however, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action will been requested at this time.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.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: 10494443
• MDR Text Key: 206955485
• Report Number: 1644019-2020-00463
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065752105
• Device Lot Number: 2290435H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1