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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEM; EYELID THERMAL PULSATION SYSTEM

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEM; EYELID THERMAL PULSATION SYSTEM Back to Search Results
Model Number 2.0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vitreous Floaters (1866); Vitreous Detachment (2445); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/27/2023
Event Type  Injury  
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 after a surgery the patient experienced posterior vitreous detachment, floater in right eye, blob in the vision that would not go away.The patient was scheduled for a second opinion with a retina specialist.
 
Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There were no samples returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.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
SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEM
Type of Device
EYELID THERMAL PULSATION SYSTEM
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 Key16713027
MDR Text Key313023573
Report Number2028159-2023-00482
Device Sequence Number1
Product Code ORZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2.0
Device Catalogue Number8065000288
Device Lot Number15515J
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received04/11/2023
Supplement Dates Manufacturer Received04/28/2023
Supplement Dates FDA Received05/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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