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

Catalog Number 8065750833

Device Problems Failure to Cut (2587); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

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.(b)(4).

Event Description

A surgeon reported the vitrector was stuck and was not cutting and he could not perform the vitrectomy procedure.The status of the aspiration was not indicated.The current status of the patients was not indicated.

Manufacturer Narrative

One opened probe received.The returned sample was visually inspected and found to be non-conforming with the inner cutter in the port and orange/brown foreign material inside and outside the port.The sample was then functionally tested for actuation, aspiration, and cut and was found conforming for all three functional tests.A photo of the product is attached to the parent file and has been reviewed by the manufacturing site.Functionality of the probe cannot be determined from the photo provided.A photo of the package label is also attached to the parent file and was also reviewed by the manufacturing site.The product and lot information seen matches what was reported.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination for device component lots traceable to the reported lot number indicates there are three additional complaints associated with the component lots for the reported issue.The returned sample was found to be functionally conforming, therefore a cut issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.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
• MDR Report Key: 8798841
• MDR Text Key: 151327781
• Report Number: 2028159-2019-01299
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFINITI SURGICAL PROCEDURE PAK; INFINITI SURGICAL PROCEDURE PAK