MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION

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  

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.

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).

Manufacturer Narrative

The phaco handpiece was not returned for evaluation.Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

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.

Event Description

New information received indicating patient symptoms were resolved and viscoelastic and procedure pak also contributed to this event.

Manufacturer Narrative

Additional information has been provided in sections b.5, b.6 and d.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15201031
• MDR Text Key: 297624140
• Report Number: 2028159-2022-01144
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121555
• 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,Followup,Followup
• Report Date: 01/11/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 08/31/2022; 12/13/2022
• Supplement Dates FDA Received: 08/30/2022; 09/28/2022; 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ADRENALINE; BETADINE 10%; BSS + ADRENALINE; CELESTENE IN SUBCONJUNCTIVAL; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; INJECTOR MEDJET MB1; INSTRUMENTATION BOX #1; INTRAVITREOUS INJ. OF DEXAMETHASONE; INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET; IV INJ. OF ANTIBIOTICS; MEDICONTOUR 640 ADY; MYDRIASERT; OCULAR 5%; PROCEDURE PAK; QUINOFREE; SOLUMEDROL BOLUS INJECTION; STERDEX; STERITRIP; TAVANIC 500MG; TOBRADEX; XYLOCAINE GEL
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male