MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 07/23/2018

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

Event Description

A scrub nurse reported during priming of the cassette of an unknown number of vitrectomy procedures the system spontaneously changed the setting of the infusion from 25g to 23g, an gave an error notice.The settings were changed manually and the procedure was completed.There was no patient involvement.This is the first of two reports being filed from this facility.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The system was manufactured on january 5, 2012.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The lot complaint history was reviewed.This is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.The returned wet posterior system cassette was visually inspected and the 25ga infusion cannula was connected to the yellow stopcock and auto infusion manifold.No obvious defects were observed.The administration, auxiliary, and the probe manifolds were not returned with the sample.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.Missing components were replaced for functional evaluation of the cassette.A calibrated console was used to test the sample.The sample could prime and pass iop calibration successfully.No anomalies were observed during priming.There were no system message codes generated during testing.Fluid flowed from the balance slat solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.There was no setting changes observed from one gauge to another as described in the report.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7971378
• MDR Text Key: 123972031
• Report Number: 2028159-2018-02169
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK; TOTALPLUS,25+ 5.0 V STD INT NS