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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that an ophthalmic coagulation probe was ineffective before the vitrectomy surgery.The surgery was completed on the same day with an alternative product without any patient impact.This report pertains to two of the two reports received from the same facility.
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.A sample is available that has not yet been received at manufacturing for evaluation the manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
The returned instrument was received in its tyvek pouch, showing the lot information.The instrument was visually inspected, and it was noted that the tube was bent.The electrical resistance measurements indicated insufficient contact, resulting in the instrument not functioning.When the instrument was opened to visually inspect the inner contacts, some of them were unintentionally destroyed during destructive instrument testing.No other defects or deficiencies could be identified on the contacts after opening the instrument.As the pouch was opened by the customer, the product had been handled.Therefore, the point in time at which the malfunction occurred can no longer be determined, nor can the stress placed on the device be reconstructed.The customer's complaint is confirmed, but the root cause of the reported issue cannot be determined.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.Non-conformance report provided by originator.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.No root cause for the customers reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.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 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 25042953
• Report Number: 3003398873-2026-00090
• Device Sequence Number: 9726143
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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