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

Model Number V3.0 CHINA

Device Problems Device Inoperable (1663); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

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.(b)(4).

Event Description

A physician reported that the poor cutting during a procedure.The probe was the cutting; however, could not cut at higher speed and the spring would not rebound.The functionality of the aspiration is unknown.The product was replaced and procedure completed with no patient harm reported.

Manufacturer Narrative

A sample was not returned and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown as no sample was returned; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened probe was received with no tip protector in a tray for the report of unable to rebound at high speed.The returned sample was visually inspected and found non-conforming with foreign matter on the cutter and the cutter stuck in the port.The sample was unable to be functionally tested due to the cutter remaining in the port.The probe was dissembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.A couple gouge marks were observed at the bend area of the inner cutter.The o-rings, spacers, diaphragm and spring are all intact.Due to the cutter remaining in the port, the probe sample was unable to be functionally tested.The evaluation did show that there was foreign matter on the cutter and gouge marks on the bend area of the inner cutter.Foreign matter, as well as a damaged inner cutter, could contribute to the reported cutting non-conformance.A damaged inner cutter, as well as foreign material, can impede the movement of the cutter shaft, causing to probe to not be able to perform the cut.How and when the inner cutter of the probe became damaged and the foreign matter was introduced cannot be determined form this evaluation.An investigation has been completed and action implemented to reduce the frequency of probe complaints.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7392984
• MDR Text Key: 104421058
• Report Number: 2028159-2018-00675
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2019

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: Physician
• Device Model Number: V3.0 CHINA
• Device Catalogue Number: 8065752912
• Other Device ID Number: 380657529124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 12/20/2018
• Supplement Dates FDA Received: 06/13/2018; 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI VITRECTOMY PAK
• Patient Outcome(s): Other