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.

Manufacturer Narrative

The reported ophthalmic oil is enrolled in the formulation stability program in which it is tested according to this product's stability specifications on a set schedule.Raw material testing is performed per requirements and disposition is based on established acceptance criteria.All compounding, pre-processing, filling, and packaging manufacturing batch records (mbrs) are subjected to two independent reviews.A single, normal level i iba ansi z1.4 for attributes is performed for every lot manufactured.The process includes a review of the following: all chemistry and microbial in-process and finished product results, environmental, utility, bioburden records, sanitization records.The reported ophthalmic oil is compounded by (1) chemical and thermal extraction, and (2) sterile filtration of oil prior to filling.The product is then filled into its primary packaging components using aseptic processing.The reported product's 10ml glass bottles and the stoppers are made from silicone.The product is terminally sterilized using dry heat.Following sterilization, units are 200% inspected for particulate in the solution and then packaged into pouches and sealed.A product insert provides instructions for proper product use.Based on the manufacturing process (sterile filtration, silicone stopper and glass vial) the root cause of the complaint condition cannot be determined.Potential root causes included: nonconforming unit - finished product testing must be acceptable prior to release.Event outside of the manufacturer's control- unable to confirm.The product labeling for the reported ophthalmic oil provides indications for use, contraindications, warnings, precautions, and directions for use to ensure proper use of the product.Instructions also state, ¿all components for single use only¿.No lot code was reported or sample provided by the customer.No further action is possible at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• 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
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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: Health Professional
• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR