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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP SCISSORS; SCISSORS, OPHTHALMIC
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ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP SCISSORS; SCISSORS, OPHTHALMIC Back to Search Results
Catalog Number 706.52
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2023
Event Type  malfunction  
Event Description
A nurse reported that during a cataract surgery an ophthalmic scissors broke inside the eye and removed on the same day.The surgery was completed with no report of patient harm.
 
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).
 
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Brand Name
GRIESHABER REVOLUTION DSP SCISSORS
Type of Device
SCISSORS, OPHTHALMIC
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 Key18550841
MDR Text Key333320950
Report Number3003398873-2024-00011
Device Sequence Number1
Product Code HNF
UDI-Device Identifier07612717066885
UDI-Public07612717066885
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number706.52
Device Lot Number15FME0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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