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

Catalog Number 8065751763

Device Problem Inability to Irrigate (1337)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/29/2022

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 physician reported that during a cataract surgery while using an ophthalmic console infusion fluid was not flowing out of the irrigation/aspiration (i/a) tips freely when it's outside the eye.The patient had experienced shallow anterior chambers during i/a and led to posterior capsule rupture and vitreous loss requiring anterior vitrectomy.

Manufacturer Narrative

No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr).The system found to meet all cosmetic and performance standards per the service test procedure (stp)."a system non-conformance based review of the batch/lot/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 lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.A complaint was opened to address a second case that the customer reported in which anterior chamber was shallow, vitreous loss occurred, and infusion was not flowing out of the i/a tips freely.The pr is in progress at the time of this investigation.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: CENTURION VISION SYSTEM
• 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: 15518451
• MDR Text Key: 300924952
• Report Number: 2028159-2022-01392
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: 00380657517633
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 12/01/2022

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: 8065751763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NON ALCON IA HANDPIECE
• Patient Outcome(s): Other; Required Intervention