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

Catalog Number 16644-08

Device Problem Obstruction of Flow (2423)

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

Event Date 09/06/2023

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 customer reported that cannulas with white corrosion and clogged orifice occurred during calibration of cataract surgery with intraocular lens (iol) implant.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 physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If possible, the customer should provide the company with a photo of the reported issue in order to help with the investigation of this complaint.A review of the reported pak's bill of materials (bom) shows there are two cannulas inside the pack: 8065420120- cannula,ant chamber,27g and oa4036j- cannula,hydrodis(chang),27gx3.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.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 and take further action, as appropriate.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: 17867267
• MDR Text Key: 324866341
• Report Number: 1644019-2023-01341
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00000000000000
• UDI-Public: 00000000000000
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16644-08
• Device Lot Number: JZ5182256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/22/2023
• 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
• Treatment: ALCON MICROSURGICAL INSTRUMENTS CANNULA OPHTHALMIC