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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number ASKU
Device Problem Particulates (1451)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/18/2022
Event Type  malfunction  
Event Description
A physician reported a piece of metal of the phacoemulsification titanium tip on the micromanipulator, in particular during the removal of the last quarter was retained in the patient's left eye during a cataract procedure.The piece was observed at the postoperative control on day 1 and the piece was very small probably less than half a millimeter.There were no complications or inflammations due to the fact that these titanium particles being biocompatible and could remain in the patient's eye.
 
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
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 a piece of metal of the phacoemulsification titanium tip on the micromanipulator, in particular during the removal of the last quarter was retained in the patient's left eye during a cataract procedure.The piece was observed at the postoperative control on day 1 and the piece was very small probably less than half a millimeter.There were no complications or inflammations due to the fact that these titanium particles being biocompatible and could remain in the patient's eye.
 
Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
PHACO TIP
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer (Section G)
ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
714 columbia avenue
sinking spring PA 19608
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key13576265
MDR Text Key285946302
Report Number2523835-2022-00049
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K161794
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2022
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
Treatment
CENTURION VISION SYSTEM, ITC.; CENTURION VISION SYSTEM.
Patient Age74 YR
Patient SexMale
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