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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065751761
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2023
Event Type  malfunction  
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 Description
A healthcare professional reported that during a cataract surgery an ophthalmic handpiece heated and tip was loose.The surgery was completed by alternate handpiece.There was no patient harm.
 
Manufacturer Narrative
The phacoemulsification handpiece was returned and during functional testing, the phaco handpiece exhibited a failure mode related to phacoemulsification performance issues, elevated shell temperature, system message (sm) [tune failed loose tip] and/or sm [u/s hp failure handpiece voltage low (short circuit)].A closed electrical circuit was confirmed using a resistance test box.These findings are consistent with the investigation performed and the root cause is attributed to piezoelectric crystals within the phaco handpiece having a high dissipation factor, causing fusion and/or shorting.Additionally, excessive application of loctite during phaco handpiece assembly was identified as a contributing factor.The root cause of the reported event can be attributed to the fusing of the crystal stack causing an electrical short circuit between the high and low electrodes.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key16633529
MDR Text Key312417550
Report Number2028159-2023-00368
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00380657517619
UDI-Public00380657517619
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K121555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/24/2023
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
Device Operator Health Professional
Device Catalogue Number8065751761
Device Lot Number13RTYD
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received03/29/2023
Supplement Dates Manufacturer Received06/28/2023
Supplement Dates FDA Received07/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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