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

Model Number V3.0 JAPAN

Device Problems Failure to Cut (2587); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

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 physician reported that a cutter could not actuate and cut during a procedure.The condition of aspiration is unknown.The product was replaced nd the procedure was completed.There was no patient harm.

Manufacturer Narrative

The returned sample was visually inspected and found non-conforming with the cutter in the port of the probe needle.The sample was then functionally conforming for actuation, aspiration and cut.The sample was found conforming for actuation and aspiration and was non-conforming for cut.The probe was disassembled 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.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.The complaint evaluation confirmed that the probe had a cut issue.The most likely root cause for the poor cutting is the observed damage to the inner cutter of the probe.A damaged inner cutter 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 cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the exact root cause for the cut issue cannot be determined from this evaluation.All probes are 100% tested for actuation, aspiration, and cut during manufacturing.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).

• 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: 8508560
• MDR Text Key: 142047838
• Report Number: 2028159-2019-00663
• 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
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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: Health Professional
• Device Model Number: V3.0 JAPAN
• Device Catalogue Number: 8065752897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI ULTRAVIT ANTERIOR VITRECTOMY PAK