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

Catalog Number ASKU

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

Patient Problems Conjunctivitis (1784); Endophthalmitis (1835); Uveitis (2122); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2022

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 that after cataract surgery by using an irrigation/aspiration (i/a) handpiece and phacoemulsification handpiece, a patient experienced severe endophthalmitis or toxic anterior segment syndrome (tass).Additional related information was requested but has not been provided to date.New information received indicating that a patient underwent cataract surgery with iol implantation in left eye with medical history of glaucoma.The patient experienced with endophthalmitis after one day of severe cataract surgery and also presented with conjunctival inflammation: 2+, cells in the anterior chamber: 3+.Patient was admitted to the emergency room with symptoms of blurred vision, and it was treated with medications antibiotic+corticosteroid 6 times a day + fluoroquinolones + antibiotics 6 times a day + antibiotics 2 times a day and also treated with intravenous injection such as intravenous injection of antibiotics + glucocorticoid injection + intravitreous injection of glucocorticoid + steroid in subconjunctival form.Event leads to change in visual acuity that reduced to light perception.Current health status of the patient disease was in process of resolution.New information received indicating patient symptoms were resolved and viscoelastic and procedure pak also contributed to this event.

Manufacturer Narrative

The customer did not retain the product lot information for this consumable procedure pack, 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.Visual inspection could not be conducted in order to ascertain the failure mode for the consumable device.A consumable is a single-use medical device provided to the customer in a sterile manner.An evaluation is conducted to ensure each fms meets customer, process, and regulatory requirements.Once the consumable is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation has taken into account the worst case to ensure all consumables 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 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 procedure paks are single-use devices provided to the customer in a sterile manner.Based on our current tracking, there are no adverse trends for this reported complaint.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: CENTURION 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: 16136440
• MDR Text Key: 307062830
• Report Number: 1644019-2023-00045
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADRENALINE; BETADINE 10%; CELESTENE IN SUBCONJUNCTIVAL; INJ MEDJET MB1; INSTRUMENTATION BOX #1; IV INJ ANTIBIOTICS; IV INJ. OF DEXAMETHASONE; MEDICONTOUR 640 ADY; MYDRIASERT; OCULAR 5%; QUINOFREE; SOLUMEDROL BOLUS INJ; STERDEX; STERITRIP; TAVANIC 500MG; TOBRADEX; XYLOCAINE GEL
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male