MAUDE Adverse Event Report: ALCON LABORATORIES, INC.; EYE LIGHT PROBE

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

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.

• Type of Device: EYE LIGHT PROBE
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 4043759
• MDR Text Key: 20781834
• Report Number: 4043759
• Device Sequence Number: 1
• Product Code: HNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1