MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER PNEUMATIC HANDPIECE DSP; UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE

Catalog Number	725.03
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 physician reported that during a combined cataract and vitrectomy surgery, the ophthalmic handpiece could not be opened or closed during insertion.The surgery was completed on the same day after replacing the product with another one and there was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in a sterilization foil bag.The original packaging was missing.The returned instrument was visually inspected.During the visual inspection, no abnormalities could be identified and no damage.The handle was then tested for functionality and no malfunctions were found.The test forceps opened and closed as expected.Therefore, the customer¿s complaint could not be confirmed.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.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.Complaint data for all manufacturer 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: GRIESHABER PNEUMATIC HANDPIECE DSP
• Common Device Name: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• 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: 22552787
• Report Number: 3003398873-2025-00329
• Device Sequence Number: 9700079
• Product Code: HQC
• UDI-Device Identifier: 07612717071391
• UDI-Public: (01)07612717071391(17)270831(11)240927(10)172WCR
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 725.03
• Device Lot Number: 172WCR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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