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

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

A nurse reported that the cutter would not work during a vitreoretinal procedure.Additional information and product sample have been requested for this report.

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).

Manufacturer Narrative

There was no probe sample returned for evaluation.A device history record review of the probe's lot was concluded.The product was released based on the manufacturer's acceptance criteria.No additional investigation is required based on the device history reviews.The root cause for the customer complaint issue cannot be determined.(b)(4).

Manufacturer Narrative

Additional information: one sample was returned for evaluation.The sample was visually inspected using 25x magnification and found to be conforming.Actuation, aspiration, and cut testing were performed and all were found to be conforming.Actuation, aspiration, and cut testing were performed and all were found to be conforming.The probe was disassembled and the components inspected.There is less than 5 minutes of wear on the inner cutter when compared to wear visual standards.Device history record reviews show that the product was released based on the manufacturer's acceptance criteria.No additional investigation is required based on the device history reviews.A complaint history examination indicates one additional complaint was associated with the probe lots.The root cause for this complaint is unknown because the returned sample was conforming to specification.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 8176152742
• MDR Report Key: 4426407
• MDR Text Key: 20783145
• Report Number: 2028159-2015-00083
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: STANDARD