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

Catalog Number 8065751617

Device Problem Air/Gas in Device (4062)

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

Event Date 03/07/2023

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 nurse reported that there was no air out; the perfusion liquid was continuously perfused during the vitrectomy surgery.Air pressure was adjusted, but it did not work.The surgery was completed after replacing the new cassette.There was no patient harm.

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.No sample was returned for root cause evaluation for this report.An investigation has been performed on prior complaints of a similar nature for the same lot.The contributing factor of these similar events has been related to pos 3 id breaking off of a posterior cassette configuration.The cassette will be recognized as a posterior cassette with manual stopcock (incorrect) but will pass priming and intraocular pressure (iop) calibration successfully.However, during fluid air exchange (fax) mode, fluid (instead of air) continued fluid flow will observed as described in this reported event.Although the console recognizes the cassette as a posterior cassette type, the broken identification (id) tab contributes to improper recognition by the console (cassette with manual stopcock).This observed issue will result in no air during fax mode.While contributing factors, such as the broken id tab and improper recognition of the posterior cassette have been identified, the root cause for these failure modes is under investigation by the manufacturing site.An action was opened to determine a root cause and corrective action was taken for complaints of a similar nature.When the internal investigation has determined root cause, actions to address root cause will be planned and completed.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.No further action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• 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: 16745861
• MDR Text Key: 313353681
• Report Number: 1644019-2023-00421
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657516179
• UDI-Public: 00380657516179
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751617
• Device Lot Number: 14UCV1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1