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

Model Number TABLETOP

Device Problem Air Leak (1008)

Patient Problem Irritation (1941)

Event Date 03/11/2016

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 vitrector was leaking a bit of air into the eye every time when aspiration was disengaged during a vitrectomy.There was no patient harm but it was irritating for the patient.The surgery was successfully completed using the same vitrector.Additional information has been requested but not received to date.

Manufacturer Narrative

A product sample was not returned.The final customer lot was identified.According to the device history record review the product was released based on the product¿s acceptance criteria.Because a sample was not returned and the lot information provided indicated the product was released to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.(b)(4).

Manufacturer Narrative

One probe sample was returned for evaluation.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was visually inspected and was deemed conforming.Actuation testing was performed and deemed conforming.Aspiration testing was performed and deemed conforming.No bubbles were observed during testing the product evaluation does not confirm the probe generated bubbles during actuation or aspiration testing.Both functional tests met specification.Air can exit the probe port if the aspiration is quickly disengaged while the cutter is still active.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5543707
• MDR Text Key: 41783021
• Report Number: 2028159-2016-01422
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2016

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: CR3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/23/2016; 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other