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

Catalog Number 316-2412-R01

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/18/2022

Event Type  malfunction  

Event Description

A customer reported the irrigation line was dislodged from the handpiece making it touch the floor causing contamination during a cataract surgery.The product was replaced and the surgery was completed.There was no patient harm.

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

Manufacturer Narrative

The customer did not retain the product lot information for this procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.A wet cassette was visually inspected.In the returned condition, the pump elastomer was removed from the cassette.No abnormality was observed on the elastomer and cassette base channel.The elastomer is pressed on the validated equipment, during production, before releasing the sample.Functional testing on the cassette could not be performed due to the returned condition of the sample.The root cause of the customer's complaint could not determine conclusively.Due to the returned sample status, functional testing could not be completed to determine the root cause of the customer's complaint.This complaint has been reviewed and it is determined that no further actions will be pursed at this time.All lots are verified that all required tests have been performed and all acceptance criteria were met.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 15578443
• MDR Text Key: 301837939
• Report Number: 1644019-2022-00811
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 316-2412-R01
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 02/01/2023
• 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