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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON GRIESHABER AG RENAISSANCE ADVANCED HANDLE; SCISSORS, OPHTHALMIC
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ALCON GRIESHABER AG RENAISSANCE ADVANCED HANDLE; SCISSORS, OPHTHALMIC Back to Search Results
Catalog Number 713.00.38
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
Event Description
A government agency reported that an ophthalmic forceps broken during a surgery.This resulted in a prolonged operation time and possibility of foreign body residues.The surgery was completed successfully by replacing the forceps with another one.There was no report of any 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).
 
Manufacturer Narrative
No sample was not received by the investigation site for evaluation.No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.However, all product and batch history records are quality reviewed prior to product release.A sample was not received at the manufacturing site therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
RENAISSANCE ADVANCED HANDLE
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 Key15192640
MDR Text Key298472993
Report Number3003398873-2022-00051
Device Sequence Number1
Product Code HNF
UDI-Device Identifier07612717068285
UDI-Public07612717068285
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number713.00.38
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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