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

Model Number 8065751592

Device Problems Break (1069); Material Separation (1562)

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

Event Date 06/30/2020

Event Type  malfunction  

Event Description

From staff: at the start of an eye case, the 23ga illuminated flexible curved laser probe broke.The part that screws into the laser port came apart and the laser plug fell to the floor.A new laser probe was opened, and the case proceeded.

• 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: 10430587
• MDR Text Key: 203680828
• Report Number: 10430587
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 07/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 87