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

Catalog Number 8065751763

Device Problems Inability to Irrigate (1337); Suction Problem (2170); Pressure Problem (3012)

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

Event Date 09/20/2022

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 in an ophthalmic console the intra ocular pressure was unstable (iop) also a vitreous prolapsed happened following an extracapsular cataract extraction (ecce).Surgeon has also noticed an unstable anterior chamber even after switching the treatment to anterior vitrectomy (a-vit).Due to the instability in the iop control in system surgeon has changed the system and the surgery was completed after converting the procedure to pars plana vitrectomy (ppv).Additional information received clarified that cataract surgery was started with ultrasound (u/s) phacoemulsification and aspiration, both perfusion and aspiration were defective from the beginning and a procedure pack failure was also suspected.The procedure was changed to ecce due to the hard nucleus and weak zinn's membrane.A-vit was performed due to a rupture of sac in the process.During the a-vit procedure unstable anterior chamber happened due to poor irrigation and the surgery was completed after changing the system.After the postoperative period, the patient was in good condition.

Manufacturer Narrative

The company representative (did not) confirm nor replicate the reported event.The system was tested and found to meet product specifications.A 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.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to meet specifications.Therefore, the root cause of the reported events 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: 15631906
• MDR Text Key: 301996188
• Report Number: 2028159-2022-01474
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: 00380657517633
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/12/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK; CENTURION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other; Required Intervention