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

Model Number LXT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

A customer reported that the cutter popped off the system during use in a vitrectomy procedure.It was also noted that the end piece fell apart.The product was exchanged to complete the case.There was no impact to the patient.

Manufacturer Narrative

The investigation is in progress.A sample has been received and is awaiting inspection.A root cause has not yet been identified.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATIN
• 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 ; 6201 south freeway, r3-48; fort worth, TX 92618-3818 ; 8176152742
• MDR Report Key: 3928682
• MDR Text Key: 4586865
• Report Number: 2028159-2014-01095
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/13/2014

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: LXT
• Device Catalogue Number: 8065751550
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2009
• 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: TOTAL PLUS PAK 25+ 5000 CUTS PER MINUTE VALVE STD
• Patient Age: 72 YR