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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number ASKU
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2023
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 physician reported that the balanced tip was bent before surgery.The product was replaced and the surgery was completed.There was no patient harm reported.
 
Manufacturer Narrative
One opened phaco tip within a wrench in a bag for the report.The returned sample was visually inspected and was found to be nonconforming; it was bent at the cone to cannula transition.Wear was visible on the threads, back of flange and the nut corners, which is consistent with threading onto a handpiece.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The returned sample is visually non-conforming with the phaco tip bent; therefore, a bent phaco tip was confirmed; however, how and when the phaco tip became bent could not be determined.Most likely root cause is handling during placement of the phaco tip onto the handpiece.The exact root cause for the bent phaco tip is unknown, therefore specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the phaco tip cannula bent exhibited on the returned opened sample, is removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CENTURION SURGICAL PROCEDURE PAK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key16943707
MDR Text Key315362427
Report Number1644019-2023-00567
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/16/2023
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 NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/05/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/16/2023
Supplement Dates Manufacturer Received07/19/2023
Supplement Dates FDA Received08/16/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CUSTOM-PAK SURGICAL PROCEDURE PACK.
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