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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 2014-07-25 for * manufactured by Alcon Laboratories, Inc..

Event Text Entries

[20781834] During surgery, the tip of eye light probe broke off of eye light instrument. The eye, surrounding field, and drapes were searched with eye microsope. The tip was not discovered in the eye or field.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4043759
• MDR Report Key: 4043759
• Date Received: 2014-07-25
• Date of Report: 2014-07-25
• Date of Event: 2014-07-18
• Report Date: 2014-07-25
• Date Reported to FDA: 2014-07-25
• Date Reported to Mfgr: 2014-08-28
• Date Added to Maude: 2014-08-28
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: EYE LIGHT PROBE
• Product Code: HNL
• Date Received: 2014-07-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON LABORATORIES, INC.
• Manufacturer Address: 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-25