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

Catalog Number 18376

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

Patient Problems Uveitis (2122); Vitritis (2181); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 05/05/2021

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.This is the second of seven reports for this reported patient event.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.The patient presented post-operative day one with significant inflammation, 3+aqueous cell noted and less than 1+vitreous inflammation.No cultures were performed.The patient was treated with additional steroid eye drops.The patient's symptoms have resolved.This report represents the second of three patients for this surgeon.

Manufacturer Narrative

No sample has been returned for evaluation; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.All the procedure paks are single-use devices provided to the customer in a sterile manner.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 the procedure paks are single-use devices 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.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: 12085786
• MDR Text Key: 258957296
• Report Number: 1644019-2021-00436
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: 18376
• Device Lot Number: 2413705H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION 15ML; BALANCED SALT SOLUTION 500ML; LIDOCAINE 1%; MOXIFLOXACIN; PC BOO (TECNIS IOL); PHENYLEPHRINE; POVIDONE IODINE 5%; TETRACAINE; TROPICAMIDE; TYLENOL; BALANCED SALT SOLUTION 15ML; BALANCED SALT SOLUTION 500ML; LIDOCAINE 1%; MOXIFLOXACIN; PC BOO (TECNIS IOL); PHENYLEPHRINE; POVIDONE IODINE 5%; TETRACAINE; TROPICAMIDE; TYLENOL
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR