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 12/17/2021

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 product under investigation is not a serviceable device.Therefore, a service record review was not performed.The root cause of the reported events is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Similar incident/event data was collected for the associated reported events.Quality assurance will continue to perform periodic monitoring for evidence of adverse trending and take further action as appropriate.Refer to the attached file.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information received indicating that a patient underwent cataract surgery with iol implantation in left eye.After 3 days of surgery the patient experienced with strong inflammation with suspicion of endophthalmitis or tass, conjunctival inflammation: 2+, cells in the anterior chamber: 3+, fibrin in the anterior chamber.Patient was treated with subconjunctival injection: glucocorticoid, other: reinforcement local corticosteroid treatment: antibiotic + corticosteroids 6 times a days; corticosteroid + antibiotic 3 times a days; fluoroquinolones + antibiotics 6 times a days.Medication was effective and patient symptoms were resolved.

Event Description

New information received indicating viscoelastic, balanced salt solution and procedure pak is also a suspect for the adverse event.

Manufacturer Narrative

Additional information has been provided in sections b.5 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: 15176304
• MDR Text Key: 297348753
• Report Number: 2028159-2022-01130
• 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,Company Representative
• 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: 07/25/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 08/30/2022; 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.; CENTURION VISION SYSTEM.; CENTURION VISION SYSTEM.; DUOVISC VISCOELASTIC SYSTEM.; DUOVISC.; INSTUMENTATON BOX N°18.; INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET.; MEDICONTUR 640 ADY 22 DIOPTRIES.; MYDRIASERT.; OCULAR 5%.; PROCEDURE PACK.; QUINOFREE.; STERDEX.; STERITRIP.; TOBRADEX.; UNSPECIFIED HP.; XYLOCAINE GEL.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Female