MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON, ENGAUGE; LASER, OPHTHALMIC

Model Number 8065751592

Device Problem Defective Device (2588)

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

Event Date 05/26/2020

Event Type  malfunction  

Event Description

From staff: the light on the alcon 23ga illuminated flexible curved laser probe was defective.Was reported the light was dim.Was asked to send back to alcon and reported as a defective device.

• Brand Name: ALCON, ENGAUGE
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 10137484
• MDR Text Key: 194625598
• Report Number: 10137484
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065751592
• Device Catalogue Number: 8065751592
• Device Lot Number: 13CLWT
• 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: 06/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 118