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

Model Number LXT-JAPAN

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 07/25/2019

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

Event Description

A customer reported that the probe did not actuate during a procedure.The condition of aspiration was unknown.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray along with other unused items, for the report of actuation failure.The returned sample was visually inspected and was found to be non-conforming with the probe needle bent at the stiffener and a small piece of the o-ring visible through the vent holes (o-ring is pinched inside engine housing).The sample was then functionally tested for actuation, aspiration, and cut and was found to be non-conforming for all three functional tests.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.The inner cutter was observed to be severely bent.Gouge marks were observed at several locations along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire enters the aspiration path but does not go through.The sample was retested with a syringe resistance was felt.After removing the extension from the coupling, foreign material was observed to be blocking the inner diameter of the inner cutter inside of the coupling.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference was removed the probe was able to actuate.The foreign material identified blocking the inner cutter inside of the coupling was analyzed using ft-ir analysis and was found to most closely match polycarbonate.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 sample evaluation confirms that the probe had an actuation failure and also indicated that the probe had a cut failure.Unrelated to the reported event, the evaluation also indicated that the probe had an aspiration failure.The most likely root cause for the observed non-conformances is from the bent needle and bent inner cutter.A damaged/bent inner cutter can impede the movement of the cutter shaft and the aspiration flow through the probe.This interference is present as observed from visual condition of the inner cutter.After the probe was disassembled (bent needle and shell removed), the probe was able to actuate.The exact root cause of the bent needle and bent inner cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site.A secondary contributing factor to the observed aspiration failure is the plastic in the inner diameter of the coupling which can partially or fully occlude the aspiration path at the cutter/coupling interface within the probe.The foreign material analysis identified one of the material as polycarbonate, which is the same material that the coupling component is composed of.An exact root cause for the bent needle and bent inner cutter was not determined from this evaluation, therefore, no specific action with regard to this root cause was taken by the manufacturing site.An internal investigation was completed and additional controls within the manufacturing process have been implemented to reduce the frequency of probe complaints for occlusions caused by shaved plastic from the coupling.All 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.No adverse trends have been observed for this reported event.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: 8894654
• MDR Text Key: 154624370
• Report Number: 2028159-2019-01499
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: 09/12/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK