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

Model Number TABLETOP

Device Problem Device Inoperable (1663)

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

Event Date 01/03/2018

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.(b)(4).

Event Description

A nurse reported that the viscous fluid control extraction did not work during a vitreo-retinal procedure.The procedure was completed.Additional information has been requested.

Manufacturer Narrative

The pneumatic modules was received for evaluation.A visual assessment of the returned sample showed no obvious nonconformities.The sample was installed into a calibrated constellation system where vfc injection pressure was found to be below specification.The valve within the cable assembly was replaced and the issue was resolved.The root cause of the reported event can be attributed to nonconforming valve.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided.The system was examined and the reported event was confirmed.The pneumatic module was replaced to resolve the issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system the root cause of the reported event can be attributed to nonconforming pneumatics module.The root cause of the reported event can be attributed to nonconforming pneumatics module.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7226597
• MDR Text Key: 98594548
• Report Number: 2028159-2018-00210
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2019

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 4.00.168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 12/20/2018
• Supplement Dates FDA Received: 04/23/2018; 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other