MAUDE Adverse Event Report: ALCON ILLUMINATED FLEXIBLE; LASER, OPHTHALMIC, ILLUMINATED, FLEXIBLE, CURVED

Catalog Number 812-2350-048

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/15/2015

Event Type  malfunction  

Event Description

During set-up, laser probe registered green light at the connection site.When it was time to use the probe, upon firing, panel turned from green to beige, signaling that it was not working.Probe connection was re-inserted twice, then to another port but still no green signal.Another probe was then used.

• Brand Name: ILLUMINATED FLEXIBLE
• Type of Device: LASER, OPHTHALMIC, ILLUMINATED, FLEXIBLE, CURVED
• Manufacturer (Section D): ALCON; 20511 lake forest dr.; lake forest CA 92630
• MDR Report Key: 5359746
• MDR Text Key: 35630222
• Report Number: 5359746
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 812-2350-048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1