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 Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Uveitis (2122); Loss of Vision (2139); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

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 customer reported that after cataract surgery patient experienced with severe endophthalmitis or toxic anterior segment syndrome with functional loss of eye.Additional information has been requested.

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).

Event Description

A patient underwent cataract surgery with iol implantation in right eye with medical history of non-insulin dependent diabetes (well-balanced).After nine days of surgery the patient experienced with severe endophthalmitis with loss of function of the eye, conjunctival inflammation: 3+, cells in the anterior chamber: 3+, fibrin in the anterior chamber, hypopyon with signs and symptoms of pain, edema of the upper eyelid, cyclitic membrane preventing examination of the vitreous.Patient was admitted in hospital treated with subconjunctival injection, intravitreous injection of antibiotics, glucocorticoid injection, intravitreous injection of glucocorticoid, steroid in subconjunctival form.Administered medication was not effective and patient symptoms were not resolved and purulent melting of the eye.This event leads to total loss of visual function and risk of purulent melting.

Manufacturer Narrative

Toxic anterior segment syndrome patient code was incorrectly reported in initial report.The manufacturer internal reference number is: (b)(4).

Event Description

New information received indicating viscoelastic, balanced salt solution and intraocular lens also a suspect for the adverse event.Current patient condition was non-resolved loss of total function with probable purulent melting of the eye.

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: 15176136
• MDR Text Key: 297347287
• Report Number: 2028159-2022-01129
• 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: 01/10/2023

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; 08/31/2022; 12/13/2022
• Supplement Dates FDA Received: 08/30/2022; 09/29/2022; 01/10/2023
• 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: 3 INTRAVITREOUS INJ. OF ANTIBIOTICS; ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; ADRENALINE; BETADINE 10%; BSS + ADRENALINE; BSS SOLUTION; BSS STERILE IRRIGATING SOLUTION; CELESTENE IN SUBCONJUNCTIVAL; CENTURION SURGICAL PAK; CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; DUOVISC VISCOELASTIC SYSTEM; I.V INJECTION OF DEXAMETHASONE; INSTRUMENTATION BOX #3; INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET; MYDRIASERT; OCULAR 5%; PROCEDURE PACK; SOLUMEDROL BOLUS INJECTION; STERITRIP; TOBRADEX; TORIC EXTENDED VISION IOL; ULTRAFLOW II I/A HANDPIECE; UNSPECIFIED IA HANDPIECE; VIVITY TORIC LENS; VIVITY TORIC LENS; XYLOCAINE GEL
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Male