MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON GRIESHABER REVOLUTION 25+; SCISSORS, OPHTHALMIC

Model Number 705.52P

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

In the process of using the 25+ grieshaber revolution scissor upon exiting the eye, doctor noticed the device had only 1 blade.Manufacturer response for 25+ grieshaber revolution scissors, (brand not provided) (per site reporter).They will pick up after the facility investigation.

• Brand Name: ALCON GRIESHABER REVOLUTION 25+
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 16627162
• MDR Text Key: 312126693
• Report Number: 16627162
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 705.52P
• Device Lot Number: 14YV5A
• 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: 03/17/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Ethnicity: Hispanic