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

Catalog Number 8065752081

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

Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Endophthalmitis (1835); Uveitis (2122); Loss of Vision (2139)

Event Date 10/02/2021

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

Event Description

A physician reported a patients eye became severely infected after a procedure was performed.The vitreous and the tubing both came back positive for a pseudomonas organism.The patient was hospitalized and required intervention.Additional information was received from the surgeon who further clarified, after an un eventful right eye phacoemulsification cataract with intraocular lens procedure, the patient had pain in the night and the next morning vision had dropped and the patient had conjunctival congestion, anterior chamber haze aqueous cell and fibrin/and no glow.A culture was taken and it was positive for endophthalmitis (pseudomonas- aeruginosa).The patient underwent a vitrectomy, anterior wash, and he was given an antibiotic intravenously (iv) intravitreal antibiotics, and topical medication adjustment.The patients current condition was stable but not improved(continuing).The product sample was not retained.

Manufacturer Narrative

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

Event Description

This is the first of eight reports for this surgeon.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The fluidics management system (fms), are single-use medical devices provided to the customer in a sterile manner.An evaluation is conducted to ensure each fms meets customer, process, and regulatory requirements.Once the fms is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation has taken into account, the worst case of the procedure pak to ensure all fms meet sterilization cycle parameters for acceptability, prior to release.A sample was not returned.Therefore, the root cause for the customer reported event cannot be determined.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.The fms 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).

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Based on our current tracking, there are no adverse trends for this reported complaint.The sample was tested using a console.The fluidics management system (fms) primed and tuned with the ultrasonic handpiece, the 0.9 millimeter (mm) air bypass tip (abs) tip and infusion sleeve from lab stock successfully.Aspiration and irrigation flow rates met specification.The tray was not returned to inspect the tyvek to tray seal profile interface and therefore we were unable to verify the condition of the product.All procedure packs 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 the tray and tyvek that houses the device was not returned for root cause evaluation.Manufacturer will not be taken for this occurrence as the root cause is unknown.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.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: INFINITI SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12739839
• MDR Text Key: 279644964
• Report Number: 1644019-2021-00679
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657520817
• UDI-Public: 00380657520817
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 8065752081
• Device Lot Number: 2447962H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AUGMENTIN.; BALANCED SALT SOLUTION WITH EPITRATE ADDITIVE.; ENTOD BALANCED SALT SOLUTION.; GALAXY FOLD SUPER PHOB INTRAOCULAR LENS IMPLANT.; MOXY BROMFENAS, UNSPECIFIED TROPICAL EYE DROPS.; POVIDONE IODINE 5%.; AUGMENTIN; BALANCED SALT SOLUTION WITH EPITRATE ADDITIVE; GALAXY FOLD SUPER PHOB INTRAOCULAR LENS IMPLANT; MOXY BROMFENAS, UNSPECIFIED TROPICAL EYE DROPS; POVIDONE IODINE 5%
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male