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

Model Number 705.52P

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

"surgeons were asking to open another 25+ grieshaber revolution curved scissors, said that the scissors did not function properly, the tip get broken.Kept one of malfunction scissor with the package label to be informed to the manufacture.Per surgeon, patient was informed about possibilities of retained scissors part in the eye and gave options for follow up treatment." manufacturer response for 25g curved scissor, alcon (per site reporter).They have taken the remaining instruments from this batch for analysis.They have supplied new replacement products.

• 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: 16582272
• MDR Text Key: 311679329
• Report Number: 16582272
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 705.52P
• Device Catalogue Number: 705.52P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female
• Patient Ethnicity: Hispanic