MAUDE Adverse Event Report: ALCON GRIESHABER AG DIATHERMY PROBE DSP; UNIT, PHACOFRAGMENTATION, ACCESSORY, PROBE

Catalog Number	339.21
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2026
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 healthcare professional reported that during vitrectomy surgery, an ophthalmic probe has not coagulated.The surgery ywas completed on the same day.The patient impact have not been provided.

• Brand Name: DIATHERMY PROBE DSP
• Common Device Name: UNIT, PHACOFRAGMENTATION, ACCESSORY, PROBE
• 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: 25635417
• Report Number: 3003398873-2026-00129
• Device Sequence Number: 15886930
• Product Code: HQC
• UDI-Device Identifier: 07612717071377
• UDI-Public: (01)07612717071377(17)280930(11)251015(10)17PU15
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: 339.21
• Device Lot Number: 17PU15
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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