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

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.

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, 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 Key: 8678860
• MDR Text Key: 147358722
• Report Number: 1610287-2019-00015
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• 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 Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• 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 Received: 08/16/2019
• 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