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

Catalog Number 8065752437

Device Problem No Flow (2991)

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

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 way to switch from intraocular pressure (iop) mode to fluid air exchange (fax) mode, and after switching to fax mode, could not get air during the procedure.The procedure was completed by changing the cassette.Additional information was requested; however, none has been received to date.

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 cassette was not returned, however, complaints of a similar nature have been received for this lot and has been related to the cassette identification (id) tab on the pinch plate being broken off.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 id tab contributes to improper recognition by the console (cassette with manual stopcock).This observed issue will result in no air during fax mode.The investigation identified several potential factors that caused or contributed to this reported event.These include: procedural gaps regarding post-inspection instructions, physical impact during storage and material movement of the pinch plate and/or cassette, and stress points due to limited surface area on the identification(id) tab.Action was taken to determine root cause and implement appropriate corrective action.To address root cause procedural enhancements were added to the visual inspection instructions for more control of non-conforming product and finite stress analysis will be performed that will aim on reducing the potential stress points on the id tabs.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: 16794683
• MDR Text Key: 313812622
• Report Number: 1644019-2023-00460
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524372
• UDI-Public: 00380657524372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 8065752437
• Device Lot Number: 14E5LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1