MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI 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); Hypopyon (1913); Iritis (1940); Fibrosis (3167); Cerebral Edema (4403); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 01/18/2023

Event Type  Injury  

Event Description

A physician reported that with the use an ophthalmic phacoemulsification handpiece patient experienced toxic anterior segment syndrome (tass) after surgery.Procedure details were not reported.Additional information has been requested but none received till 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).

Event Description

Additional information received clarifying that patient had experienced conjunctival inflammation: x+2, aqueous cell: x3+ , aqueous fibrin: present , hypopyon: present, eye pain and corneal edema.Patient was prescribed with post operative eye drops such as antibiotics/corticosteroids drops and non-steroidal anti-inflammatory drugs.Before the event patients best corrected visual acuity was 0.2 in right eye and 0.05 in left eye.Best corrected visual acuity after the evet was 0.9+ in right eye and : 0.9- in left eye.Patient condition was resolved.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Additional information was provided in sections h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no product returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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).

• Brand Name: INFINITI 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: 16378239
• MDR Text Key: 309559385
• Report Number: 2028159-2023-00203
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K112425
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: APROCAM.; CENTURION VISION SYSTEM (ACTIVE SENTRY).; CENTURION VISION SYSTEM WITH ACTIVE SENTRY.; DICLOABAK.; DUOVISC VISCOELASTIC SYSTEM.; DUOVISC.; TOBRADEX.
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Sex: Female