* E0578L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-05 for * E0578L manufactured by Storz Ophthalmic Division Of Bausch & Lomb, Inc..

Event Text Entries

[264447] Tip of instrument broken off in pt's eye while physician using ultrasonic handpiece to emulsify cataract. Tip retrieved by surgeon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027735
• MDR Report Key: 446884
• Date Received: 2003-03-05
• Date of Report: 2003-03-04
• Date of Event: 2003-02-12
• Date Added to Maude: 2003-03-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: NAGAHARA NUCLEUS CHOPPER
• Product Code: HNQ
• Date Received: 2003-03-05
• Model Number: E0578L
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 435846
• Manufacturer: STORZ OPHTHALMIC DIVISION OF BAUSCH & LOMB, INC.
• Manufacturer Address: 3365 TREE COURT INDUST BLVD ST. LOUIS MO 63122 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-03-05