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

Catalog Number ASKU

Device Problem Contamination (1120)

Patient Problem Eye Pain (4467)

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 patient complained of pain in the eye after surgery surgeon noticed that it was a gauze fiber in the eye it was observed when patient came for the post operative appointment and another surgery was scheduled to remove the gauze fibers from the eye there was no deficiency noted prior, removed fiber was not available for return.The pack was used to complete the procedure and it was removed from eye by vacuuming out through irrigation or aspiration process.No photos were available.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, deviation history report (dhr) and lot history could not be reviewed.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.A review of the reported pak's bill of materials (bom) shows each unit should include (1pk) kn7317- sponge,gauze,16ply,xry,4x4,10s.A review of the deviation history report could not be reviewed as the customer did not retain the affected lot information.However, a different complaint record for a sister pak for the same customer shows there was a temporary deviation applied on the unavailable kn7317- sponge,gauze,16ply,xry,4x4,10s to be substituted with available alternative menon25430- sponge,gauze,16ply,xry,4x4.A review of the sap where-used parts list could not be reviewed as the customer did not retain the affected lot information.One recommendation is that the customer contact their account manager about placing the sponge gauze in a glassine bag in their paks.Doing this would help prevent the potential spread of lint from the gauze and the transfer of lint from other products onto the gauze.Additionally, the account manager can work with the houston sales admin team for suggestions on low-lint products.The root cause of the customer's complaint could not be established conclusively as a sample has not been received.Without a sample, it is not possible to isolate the root cause.Manufacturing records were not able to be reviewed as the customer did not retain the affected lot information.No action will be pursued at this time for this occurrence.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Based on current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK 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: 16627566
• MDR Text Key: 312126018
• Report Number: 1644019-2023-00327
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other