HIGH SPEED VITRECTOMY CUTTER CX4804

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-26 for HIGH SPEED VITRECTOMY CUTTER CX4804 manufactured by Bausch & Lomb.

Event Text Entries

[17030077] The vitrectomy cutter failed to cut properly during use. There were no patient problems.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1920664-2007-00367
• MDR Report Key: 835881
• Report Source: 06
• Date Received: 2007-03-26
• Date of Report: 2007-02-28
• Date of Event: 2007-01-10
• Date Mfgr Received: 2007-02-28
• Device Manufacturer Date: 2006-08-01
• Date Added to Maude: 2007-04-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: JANET LACAVICH
• Manufacturer Street: 3365 TREECOURT INDUSTRIAL BLVD
• Manufacturer City: ST. LOUIS MO 63122
• Manufacturer Country: US
• Manufacturer Postal: 63122
• Manufacturer Phone: 6362263213
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HIGH SPEED VITRECTOMY CUTTER
• Generic Name: OPHTHALMIC MICROSURGICAL ACCESSORY PARK
• Product Code: HNM
• Date Received: 2007-03-26
• Model Number: NA
• Catalog Number: CX4804
• Lot Number: T7646
• ID Number: NA
• Device Expiration Date: 2008-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 823175
• Manufacturer: BAUSCH & LOMB
• Manufacturer Address: * ROCHESTER NY 14609 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-03-26