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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC PERFLUORON FLUID, INTRAOCULAR

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ALCON RESEARCH, LLC PERFLUORON FLUID, INTRAOCULAR Back to Search Results
Catalog Number 8065900113
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/21/2020
Event Type  Injury  
Manufacturer Narrative
A sample is available that has not yet been received at manufacturing for evaluation. Investigation including root cause analysis is in progress. This is the first of two reports for this reported event. The manufacturer internal reference number is: 2020-50847.
 
Event Description
A physician reported that ophthalmic perfluoro-n-octane liquid with possible silicone oil was noted to have migrated under a patient's conjunctiva resulting in a subconjunctival hemorrhage and an unspecified corneal defect after an unspecified surgery. Additional information has been requested. Additional information received confirmed that an additional procedure was performed in order to remove the residue from under the conjunctiva.
 
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Brand NamePERFLUORON
Type of DeviceFLUID, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
6201 south freeway
fort worth TX 76134
Manufacturer (Section G)
ALCON RESEARCH, LLC
6201 south freeway
fort worth TX 76134
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key10570184
MDR Text Key208088096
Report Number1610287-2020-00024
Device Sequence Number1
Product Code LWL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P950018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8065900113
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/22/2020 Patient Sequence Number: 1
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