MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON SMALL PART KIT; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751526

Device Problems Material Integrity Problem (2978); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

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.(b)(4).

Event Description

A healthcare professional reported that the sleeve material was softer and a different color; the sleeves did not stand the pressure in the incision and the surgeon had to readjust.There was no patient impact.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received.The reporter indicated that the procedure being performed was a cataract surgery.The procedure was completed with the same sleeve.

Manufacturer Narrative

Additional information provided in h.3, h.6 and h.10.The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.A review of the inspection records for this lot indicated dimensional, visual inspection, product translucent red (pms 500) verification and twist test was performed and all acceptance criteria were met.The supplier hardness test record results were then reviewed and demonstrated the infusion sleeve lot met specifications during evaluation.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.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.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: SMALL PART KIT
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9350105
• MDR Text Key: 174678484
• Report Number: 1644019-2019-00180
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 8065751526
• Device Lot Number: 2260747H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 01/15/2020
• Supplement Dates FDA Received: 12/24/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PAK.