MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION VISION SYSTEM, ACCESSORY, INFUSION TUBING SET; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750914

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

A physician reported the interface of the gas-liquid exchange tube was found to be broken during a vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.

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).

Manufacturer Narrative

Additional information provided in h.6 and h.10.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.Based on current tracking, there are no adverse trends for this reported complaint.The customer reported that the interface of the tubing was found broken when the pack was opened.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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 returned sample was visually inspected and a kink was observed in the infusion manifold.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The sample was tested with the lab stock cassette and the other components.The sample could prime and pass iop calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.The kink on the infusion manifold did affect the functionality of the sample returned.The root cause of the customer's complaint is the kink in the infusion manifold which would occur during the supplier manufacturing process.The kink on the infusion fluid line prevented fluid from flowing through the infusion cannula and would result in failure to prime.After an investigation of this complaint, it has determined that no further actions will be pursued at this time.The supplier has been made aware of the issue and the sample of similar nature has been sent to the supplier for additional analysis.No adverse trends have been observed associated with the reported product and event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM, ACCESSORY, INFUSION TUBING SET
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14160183
• MDR Text Key: 289666717
• Report Number: 1644019-2022-00291
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657509140
• UDI-Public: 00380657509140
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2022

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 8065750914
• Device Lot Number: 2482515H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 07/07/2022; 10/31/2022
• Supplement Dates FDA Received: 07/22/2022; 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1