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

Catalog Number 8065750914

Device Problems Complete Blockage (1094); Defective Device (2588)

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

Event Date 07/25/2022

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 the tubing was damaged and blocked during a vitrectomy surgery.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

Additional information received in d.9., h.3., 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.The used infusion manifold was visually inspected and no obvious defect was found.The snap clamp could be opened and closed as needed.The sample was tested with the lab stock components on a calibrated console.Fluid flowed to the infusion line, but no air flowed to the air line in the default setting of 35 mmhg.The auto infusion valve (aiv) manifold was then tested separately.An external pressure source was used to perform a opening pressure test.The pressure was incrementally increased until the valve actuated.The aiv was found to be non-conforming due to the higher than expected opening pressure.Since the aiv subsequently actuated manually after reestablishing the opening during laboratory testing, it¿s possible a fraction of the silicone valve lips self-adhered and potentially contributed to the higher than typical cracking pressure observed.The root cause of the stuck valve could not be conclusively determined.After macro analysis of the returned sample, the most probable root cause of the customer¿s event could be attributed to self-adhesion.Since the aiv subsequently actuated and functioned after reestablishing the opening, it¿s possible a fraction of the silicone valve lips self-adhered and potentially contributed to the higher than typical cracking pressure observed.Action will not be taken for this occurrence as the root cause is not known.After a thorough investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.A trend analysis for this lot shows this event to be isolated to a single occurrence.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: 15183758
• MDR Text Key: 301350404
• Report Number: 1644019-2022-00659
• 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
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 8065750914
• Device Lot Number: 2445337H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1