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 six patients experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.A completed questionnaire was received.There were no complications reported during the surgery.The patient required additional medical treatment with compounded antibiotic, steroid and non-steroidal drops in the right eye.Current patient condition was not reported.This report represents patient four of the six patients 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 custom pak is an assemblage of single-use medical devices and accessories provided to the customer in a sterile manner.An evaluation is conducted to ensure each pak and item in the pak meets customer, process, and regulatory requirements.Several sizes are available to accommodate the best fit for the custom pak.Once the custom-pak is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation has taken into account the worst case of the pouches to ensure all custom paks meet all sterilization cycle parameters for acceptability prior to release.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.Custom 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: 11826872
• MDR Text Key: 250691171
• Report Number: 1644019-2021-00337
• 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
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSS WITH EPINEPHINE 1:1000; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; INFINITI VISION SYSTEM; OFLOXACIN 0.3%; PHENYLEPHRINE 2.5; PROPARACAINE; SODIUM BICARB; TROPICANIDE 1%; BSS WITH EPINEPHINE 1:1000; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; INFINITI VISION SYSTEM; OFLOXACIN 0.3%; PHENYLEPHRINE 2.5; PROPARACAINE; SODIUM BICARB; TROPICANIDE 1%
• Patient Outcome(s): Required Intervention