MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON, ENGAUGE; PHOTOCOAGULATOR AND ACCESSORIES

Model Number 8065751593

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Event Description

Tip of laser not illuminating - surgeon was able to finish laser portion of the surgery but outcome was not optimal.Product had patient contact but no patient harm.Product is available to be returned to the manufacturer.

• Brand Name: ALCON, ENGAUGE
• Type of Device: PHOTOCOAGULATOR AND ACCESSORIES
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 8338843
• MDR Text Key: 136127692
• Report Number: 8338843
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065751593
• Device Catalogue Number: 8065751593
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA