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

Catalog Number 8065750469

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

Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Uveitis (2122); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2022

Event Type  malfunction  

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) with functional loss of eye.Additional related information was requested but has not been provided to date.This is the third of three reports for the reported event from this facility.

Manufacturer Narrative

The phacoemulsification (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.The 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

Upon additional corrected information received, the previously reported fda patient code "4469" was not experienced by the patient.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received indicating that the cataract surgery was completed without complications.The patient presented with endophthalmitis two days after the surgery.The patient presented with conjunctival inflammation: 3+; cells in the anterior chamber: 3+; fibrin in the anterior chamber; and hypopyon.The patient had pain, edema of the upper eyelid, and cyclitic membrane preventing examination of the vitreous.The patient went to the emergency room and was hospitalized for seven days and had intravitreous injection of antibiotics, glucocorticoid bolus injection, intravitreous injection of corticosteroid, steroid in sub conjunctival form.The action was effective.The patient¿s visual acuity recovered to normal and all the symptoms have been resolved.This is the third of three reports for the reported event from this facility.

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL 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: 15198685
• MDR Text Key: 297703490
• Report Number: 2028159-2022-01143
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• 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
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• 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: 08/10/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 08/31/2022
• Supplement Dates FDA Received: 08/30/2022; 09/29/2022
• 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: BETADINE 10% ON THE EYELIDS: PRE-OP TREATMENT; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; DUOVISC VISCOELASTIC SYSTEM; IRRIGATION SOLUTION USED: BSS + ADRENALINE; OCULAR 5% FOR 3 MINUTES: PRE-OP TREATMENT; STERITRIP: PRE-OP TREATMENT
• Patient Age: 76 YR
• Patient Sex: Female