MAUDE Adverse Event Report: ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH LTD.) 25G FLEXIBLE TIP LASER PROBE; LASER OPHTHALMIC

Lot Number 17013666X

Device Problem Break (1069)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

During eye procedure, surgeon attempting to put probe through trocar during which time the tip broke off the instrument.Eye was examined, no foreign body found.Operative field searched, tip was not found.No apparent pt harm.Fda safety report id# (b)(4).

• Brand Name: 25G FLEXIBLE TIP LASER PROBE
• Type of Device: LASER OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH LTD.)
• MDR Report Key: 8707766
• MDR Text Key: 148477130
• Report Number: MW5087420
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 17013666X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1