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

Model Number LXT-JAPAN

Device Problem Activation Problem (4042)

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

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 the cutter did not actuate during a procedure.The condition of aspiration is unknown.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The returned sample was visually inspected and found non-conforming with orange/brown foreign material on the port face and needle.The sample was then functionally tested 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.Gouge marks were observed at several locations along the inner cutter.Damage was observed on the cutting edge of the inner cutter.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 complaint evaluation did not confirm that the probe had an actuation failure.The evaluation indicated that the probe had a cut failure.The most likely root cause for the poor cutting is the observed damage/wear to the inner cutter of the probe.A damaged/worn inner cutter can decrease the quality of the cut performed by the probe.How and when the inner cutter of the probe became damaged/worn cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the evaluation did not confirm an actuation failure and 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: CONSTELLATION 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: 9176235
• MDR Text Key: 172058892
• Report Number: 2028159-2019-01834
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• 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: 12/19/2019

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: LXT-JAPAN
• Device Catalogue Number: 8065752043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK