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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC SILIKON 1000 OIL FLUID, INTRAOCULAR

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ALCON RESEARCH, LLC SILIKON 1000 OIL FLUID, INTRAOCULAR Back to Search Results
Catalog Number 8065601187
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/21/2020
Event Type  Injury  
Manufacturer Narrative
No sample or lot number information has been received by manufacturing for evaluation. 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. This is the second of two reports for this reported event. The manufacturer internal reference number is: (b)(4).
 
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 NameSILIKON 1000 OIL
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 Key10570357
MDR Text Key208088492
Report Number1610287-2020-00025
Device Sequence Number1
Product Code LWL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P950008
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 Number8065601187
Device Lot NumberASKU
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
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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