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

Catalog Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

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

An ophthalmic surgeon reported that a patient experienced toxic anterior segment syndrome (tass) postoperatively.Patient and procedure outcome are unknown.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information provided in b.2, b.5 and h.10.This event does not meet criteria as a reportable malfunction based on information received following submission of the initial report.With current information received from the facility, it has been determined that our device was not the contributory cause of the event.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received.The facility does not feel the reported events are associated with the reported device and informed they were reporting for information purposes.

• 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
• MDR Report Key: 11330805
• MDR Text Key: 231934079
• Report Number: 1644019-2021-00095
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: ASKU
• Device Lot Number: 2412344H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 15 ML BALANCED SALT SOLUTION; 500 ML BALANCED SALT SOLUTION; CENTURION SURGICAL PROCEDURE PACK; DUOVISC; 15 ML BALANCED SALT SOLUTION; 500 ML BALANCED SALT SOLUTION; CENTURION SURGICAL PROCEDURE PACK; DUOVISC
• Patient Outcome(s): Other