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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Alcon Grieshaber AG Diathermy Probe DSP; Unit, Phacofragmentation, Accessory, Probe
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Alcon Grieshaber AG Diathermy Probe DSP; Unit, Phacofragmentation, Accessory, Probe Back to Search Results
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 07/06/2026
Type of Reportable Event Malfunction
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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
+1(800)757-9780
MDR Report Key50099184
Report Number3003398873-2026-00163
Device Sequence Number18761680
Product Code HQC
UDI-Device Identifier07612717071377
UDI-Public(01)07612717071377(17)290228(11)260309(10)17YWDL
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K063583
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/31/2026
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 Number339.21
Device Lot Number17YWDL
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/27/2026
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer 07/08/2026
Initial Report FDA Received Date07/31/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/09/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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