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 Problems Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 customer reported that they have patient's that have experienced toxic anterior segment syndrome (tass).A completed questionnaire was received indicating the patient received medical treatment in the right eye of a adrenocortical steroid injection.An antibiotic, steroid and non-steroidal were administered to the patient.This is the first of six (6) reports from this facility.

Manufacturer Narrative

The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A pik pak is an assemblage of single-use medical devices and accessories provided to the customer in a sterile manner.All components built into the paks are sterilized prior to assembly and then shipped to the customer for use.The root cause of the customer's complaint could not be established as a sample has not been received and therefore the condition of the product could not be verified.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.Pik pak and the components inside of the paks are single use items provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No additional action is required at this time.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
• MDR Report Key: 11832801
• MDR Text Key: 251144762
• Report Number: 1644019-2021-00345
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION WITH EPI; BROMDAY; CELESTONE 0.1CC; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; INFINITI VISION SYSTEM; INVELTYS; PHENYLEPHRINE 2.5%; POLYMIXIN; PROPARACAINE; SODIUM BICARB; SP AS ASPHERIC UV ABSORBING; TROPICAMIDE 1%
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR