MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CONSTELLATION VITRECTOMY TOTAL PLUS PAK; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751462

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Green tubing was broken inside pack, found while setting up for procedure.Manufacturer response for virectomy pak, (brand not provided) (per site reporter).
=
took down description of problem, issued rga#.Sent shipping label to return product.

• Brand Name: CONSTELLATION VITRECTOMY TOTAL PLUS PAK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 4289500
• MDR Text Key: 5052577
• Report Number: 4289500
• Device Sequence Number: 1
• Product Code: HQC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 8065751462
• Device Lot Number: 1574878H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2014
• Patient Sequence Number: 1
• Patient Age: 82 YR