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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-10 for * manufactured by Bausch-lomb Storz Instrument Co..

Event Text Entries

[309165] During cataract surgery, phaco process, osher lens manipulator tip broke off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1031477
• MDR Report Key: 516449
• Date Received: 2004-03-10
• Date of Report: 2004-02-25
• Date of Event: 2004-02-12
• Date Added to Maude: 2004-03-22
• 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: 3
• 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: MANIPULATOR - OSHER NUCLEUS 0.5 MM
• Product Code: HRK
• Date Received: 2004-03-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 505476
• Manufacturer: BAUSCH-LOMB STORZ INSTRUMENT CO.
• Manufacturer Address: 3635 FREECOURT INDUSTRIAL BLVD ST LOUIS MO * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-03-10