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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 Problems Myocardial Infarction (1969); Paralysis (1997); Weakness (2145); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
No sample or lot number information has been received by manufacturing for evaluation in conjunction with this literature report. 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. Additional information is not available for this report. The manufacturer internal reference number is: (b)(4).
 
Event Description
A physician in a literature report reported that ophthalmic oil was instilled into a patient's right eye to treat diabetic retinopathy. Afterwards, the patient experienced a weakness in the right upper and lower limbs, shoulder and face paralysis, dysarthria and, upon mri and ct testing, was noted to have experienced an acute infarction of the left medulla oblongata with intraventricular oil migration. The literature report stressed the importance to diagnose between bleeding and ophthalmic oil migration into the intraventricular area.
 
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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
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8678860
MDR Text Key147358722
Report Number1610287-2019-00015
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,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
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 Received08/16/2019
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: 06/07/2019 Patient Sequence Number: 1
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