MAUDE Adverse Event Report: ALCON GRIESHABER AG BACKFLUSH HANDLE DSP; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY

Catalog Number	337.88
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
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 physician reported that during the surgery, ophthalmic tip could not be inserted into trocar during insertion.It was unknown whether the surgery was completed or not.The involved eye and the patient identifier are not available.There was no patient harm.The procedure type was unknown.
Additional Manufacturer Narrative
The investigation is completed.The sample was received with inner blister, outer blister and cover foil showing the lot information.The sample shows no macroscopic signs of damage.The sample shows signs of surgery residues and after cleaning no more residues were visible.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was visually inspected and measured physically.The measurement shows that the shaft of the device corresponds to the manufacturer¿s specification.The sample was also tested with an internal inspection equipment representing the alcon cannula and it was noticed that the device was able to be inserted without any issues.The customers complaint is therefore not confirmed.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.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: BACKFLUSH HANDLE DSP
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY
• 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: 17150746
• Report Number: 3003398873-2023-00074
• Device Sequence Number: 20338815
• Product Code: HQE
• UDI-Device Identifier: 07612717071414
• UDI-Public: 07612717071414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K884043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 337.88
• Device Lot Number: 14TCX0
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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