MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751617

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Intraocular Pressure Decreased (4468)

Event Date 05/17/2021

Event Type  Injury  

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 infusion cannula detached during air-silicone exchange.The patient experienced hypotony for several minutes associated with macular subretinal hemorrhage.

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided indicating cannula did not break and the surgery was completed during the same procedure.

Manufacturer Narrative

Additional information provided in b.5., 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 returned sample was visually inspected.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.The silicone tubing with the infusion cannula tip detached from the straight though connector in the returned condition.Indentation mark on the tubing appeared that the tubing was once attached to the straight though connector.The diameter of the fitting was flat in an oval shape.A calibrated console representing the current software version was used to test the sample.The ball in the drip chamber¿s check valve moved freely per specification.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The misshape on the fitting diameter did not prevent the fluid from flowing.The supplier investigated retained samples and production records from the supplier lot in question and inspection did not indicate any anomalies occurred during the manufacturing of the suspect lot.If any equipment were to cause this type of damage, a fault report would have been filed and more product would have been noted as damaged.Review of maintenance records did not reveal any issues with production or packaging equipment.No additional complaints have been reported.Upon microscopic examination of the returned sample, one of the barbs is severely compressed and 25% of the barb edge is damaged.Deep striation on the damaged barb tip, along with severe compression, indicates excessive external forces were applied.Drag marks indicate metal or hard plastic peeled over the barb edge and extended to the barb tip.After an analysis and based on the condition of the sample, the root cause is potentially related to an error during the suppliers assembly process.The supplier performed a root cause evaluation and determined the damage was caused by external factors not part of their manufacturing process.After an investigation of this complaint, it has determined that no further actions will be pursued at this time.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 SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11866961
• MDR Text Key: 252373605
• Report Number: 1644019-2021-00356
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657516179
• UDI-Public: 00380657516179
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065751617
• Device Lot Number: 2394196H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 05/26/2021; 08/19/2021
• Supplement Dates FDA Received: 06/03/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Other
• Patient Age: 8 YR