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

Model Number TABLETOP

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907)

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

Event Date 07/24/2018

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 customer reported that during setup for surgery, the vitrectomy cutter did not work and the "pneumatic module fell out".The procedure was cancelled.

Manufacturer Narrative

Additional information provided.The company service representative examined the system and found the vitrectomy cutter to be jamming.The company service representative replaced the vitrectomy cutter and restarted the system.Unrelated to the reported event, the company service representative found system message (sm) - [illuminator ballast thermo-cut-off has been triggered.Illuminator functions will be disabled].The system was then tested and met all product specifications.The system was manufactured on october 25, 2011.Based on qa assessment, the product met specifications at the time of release.No vitrectomy probe sample was returned for evaluation for the report of vitrectomy cutter not working; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot number history and complaint history reviews could not be conducted.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 system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.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: 7798011
• MDR Text Key: 117837408
• Report Number: 2028159-2018-01748
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED VITRECTOMY PROBE
• Patient Outcome(s): Other