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

Model Number TABLETOP-JAPAN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

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.(b)(4).

Event Description

A physician reported that a cutter did not actuate during a procedure.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.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.A complaint history examination for device component lots traceable to the reported lot number indicates there are two additional complaints associated with the component lots for the reported issue.A sample was not received at the manufacturing site 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 the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; 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

Additional information provided in d.10, h.3, h.6 and h.10.One opened probe was received for evaluation.The returned sample was visually inspected and found non-conforming with orange/brown foreign material on the port face, welded cap and needle.The probe was then functionally tested for actuation, aspiration, and cut.The sample was found conforming for actuation and was non-conforming for aspiration and cut.The probe sample was disassembled and the components inspected.Nominal 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 the cutting edge and several other locations along the inner cutter.The sample was tested with a syringe and resistance was felt.A wire was inserted through the aspiration path to remove the interference.The sample was retested with a syringe and no resistance was felt.The sample was retested for aspiration with the probe driver and was able to aspirate.The initial aspiration test failed due to an interference in the aspiration path and once the interference was removed the probe was able to aspirate.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 does not confirm that the probe sample had an actuation failure.The evaluation indicated that the probe had aspiration and cut failures.The root cause for the aspiration failure is due to foreign material in the aspiration path.How and when foreign material was introduced into the aspiration path cannot be determined from this evaluation; however, the foreign material is most likely surgical material from the surgical use of the probe.The most likely root cause for the observed cut failure 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.Action taken: the probe sample was able to aspirate once the observed interference was removed and the exact root cause for the cut failure cannot be determined from the evaluation performed, therefore, no specific action with regard to this complaint was taken by the manufacturing site with regard to the reported customer complaint.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.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: 8797772
• MDR Text Key: 151422444
• Report Number: 2028159-2019-01296
• 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,Followup
• Report Date: 03/16/2020

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 Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 03/14/2020
• Supplement Dates FDA Received: 10/22/2019; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK