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

Catalog Number 8065752914

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).

Manufacturer Narrative

Additional information was provided in sections a.1, a.2, a.3, b.3, b.5, b.6, d.10 and h.6.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

Based on the information received following submission of the initial report, it is clarified that the unspecified phacoemulsification handpiece not suspected for the reported event.The updated report for the suspected handpiece has been submitted under mfg report num.2028159-2023-00203.No further reports will be scheduled under mfg report num.2028159-2023-00202.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY 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: 16378240
• MDR Text Key: 309559410
• Report Number: 2028159-2023-00202
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K161794
• 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: 04/20/2023

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: 8065752914
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 03/27/2023
• Supplement Dates FDA Received: 03/28/2023; 04/20/2023
• 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: APROCAM; CENTURION VISION SYSTEM WITH ACTIVE SENTRY; DICLOABAK; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; HANDPIECE; INFINITI VISION SYSTEM, ACCESSORY, HANDPIECE; TOBRADEX
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Sex: Female