MAUDE Adverse Event Report: ALCON GRIESHABER AG MONARCH II LOADING FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	560.01
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that ophthalmic forceps did not close properly during cataract surgery.There was a patient contact and no patient harm.Procedure was completed on same day.
Additional Manufacturer Narrative
The investigation is completed.No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.No sample expected.A sample was not received at the manufacturing site therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that during cataract surgery, ophthalmic forceps did not close properly.There was a patient contact and no patient harm.Procedure was completed on same day.

• Brand Name: MONARCH II LOADING FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16403125
• Report Number: 3003398873-2023-00027
• Device Sequence Number: 5378732
• Product Code: HNR
• UDI-Device Identifier: 07612717057470
• UDI-Public: 07612717057470
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 560.01
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF SINGLEPIECE IOL; ACRYSOF SINGLEPIECE IOL; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH II LOADING FORCEPS; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown