MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750833

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

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.A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported the cassette tubing was permanently kinked and someone had to hold it open with their fingers during the entire surgical procedure.There was no harm to the patient.

Manufacturer Narrative

Additional information provided in g.1., g.2.H.3., h.6., and h.10.The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.The wet returned sample was visually inspected and a piece of surgical tape was wrapped around the admin tubing.The administration tubing was bent at 6" near the cassette insertion.The sample was then tested on a calibrated console and could prime and tune with the ultrasonic handpiece successfully.Irrigation flow performance was measured with the bent tubing and the sample met specifications.The cassette fluidics calibrated and functioned per specifications during laboratory evaluation.The root cause of the customer's complaint is related to an error that can occur during the insertion of the product into the procedure pack prior to sealing.The tubing was possibly bent acutely when positioned into the container tray (prior to sealing).Action will not be taken for this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9295243
• MDR Text Key: 173696874
• Report Number: 2028159-2019-02032
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

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: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI SURGICAL PROCEDURE PAK.