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

Catalog Number 8065750833

Device Problems Failure to Cut (2587); Appropriate Term/Code Not Available (3191)

Patient Problems Prolapse (2475); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

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 customer reported that in an ophthalmic console exhibited with problem with vitrectomy.Procedure details and patient impact have not been provided.Additional information received indicated that during a cataract extraction with intraocular implant surgery.The surgeon found necessary to switch to a vitrectomy procedure.While the surgeon was trying to use vitrectomy probe an occlusion message was displayed.The cannulas and the probes were flushed and re-primed which did not resolve the issue.The vitrectomy probe was not cutting at all.A new probe was obtained and this one had intermittent cutting.No system message(sm) was displayed for the second probe.The surgery was completed without harm to the patient.

Manufacturer Narrative

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

Event Description

Addition information was received indicating the patient experienced a tear in the capsular bag.The surgeon had to convert to an anterior vitrectomy due to vitreous coming into the front of the eye.

Manufacturer Narrative

The company service representative examined the system and was unable to confirm or replicate the reported events of a cutting issue or system message.The system was then tested and met all product specifications.A system 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.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: INFINITI 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: 12849760
• MDR Text Key: 281083432
• Report Number: 2028159-2021-01372
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

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: 8065750833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/20/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 03/11/2022
• Supplement Dates FDA Received: 01/25/2022; 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK
• Patient Outcome(s): Other; Required Intervention