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

Catalog Number	337.84
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 nurse reported that, before a vitrectomy surgery, the suction function of an ophthalmic backflush soft tip was not working.The procedure was completed on the same day by replacing the tip with a new one, without causing any harm to the patient.Additional information was requested but has not been received to date.
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3, h.6 and h.11.One returned instrument was received in its outer blister, and the other one in its inner and outer blister, both were covered by the tyvek foils shows the lot information.One of the instrument shows that the tube is bent.The other one show no macroscopic sign of damage.The returned instruments were visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection showed that the soft tip of the first instrument is torn off, the other one showed no abnormalities.The instrument which no damage occurred was then functionally tested regarding their aspiration/irrigation properties.It could be shown that there is no leakage and no occlusion of the instrument and the aspiration as well as the irrigation works as expected for the instrument.As the blisters were opened by the customer, the products were handled.Therefore, the point in time when the defect of one of the products 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.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.It cannot be determined how or where the damages to the instrument occurred.Therefore, a root cause for the customer's reported event could not be determined conclusively.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufactured products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.The complaint data will continue to be monitored for evidence of adverse trending and further action will be taken, as appropriate.No further action warranted at this time.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: 22874459
• Report Number: 3003398873-2025-00358
• Device Sequence Number: 20277627
• Product Code: HQE
• UDI-Device Identifier: 07612717071193
• UDI-Public: (01)07612717071193(17)271130(11)241210(10)1768CD
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: 337.84
• Device Lot Number: 1768CD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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