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

Catalog Number	560.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a cataract extraction with intraocular lens procedure an ophthalmic forceps tip did not look secured and upon further inspection the tip fell off on to the sterile field.Procedure was completed with backup forceps with no patient impact.
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).
Additional Manufacturer Narrative
A manufacturing device history record (dhr) review was performed to ensure that the product was manufactured in compliance with the device master record.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any deviation and that there are no additional complaints associated with it.The sample was received taped onto a sheet of carton packed in a zip-lock bag.The sample evidently shows macroscopic signs of damage, namely that one of forceps arms is broken off at the location where the arm changes thickness, i.E., at its weakest point.The fracture surface of the sample was visually inspected and did not show any abnormalities that would indicate a root cause for the breakage.The product is a reusable device intended to be cleaned/sterilized by the customer and has been in use per the initial description.Therefore, product was handled and the situation in which the defect occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is therefore confirmed but the root cause cannot be identified by this investigation.It cannot be determined how or where the damage to the sample occurred.Therefore, a root cause for the customer's reported event could not be determined.The exact root cause for the customer's 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).

• 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: 18343842
• Report Number: 3003398873-2023-00222
• Device Sequence Number: 5380649
• Product Code: HNR
• UDI-Device Identifier: 07612717057470
• UDI-Public: 07612717057470
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 05/05/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown