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 Intraocular Pressure Increased (1937); Loss of Vision (2139)

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.(b)(4).

Event Description

In a literature report, a physician reported that ophthalmic oil was injected into a patient's right eye during a combination cataract and vitrectomy surgery after which the patient experienced elevated intraocular pressure (iop), vision loss and phthisis bulbi which was attributed to migration of the oil product from the eyeball into the right optic nerve and optic chiasm then passing through and into the subarachnoid space.

Manufacturer Narrative

No lot code was reported by the customer therefore, lot specific evaluation cannot be completed.All compounding, preprocessing, filling and packaging mbrs are subjected to 2 independent reviews.In addition, the following are reviewed: all chemistry and microbial finished product results; environmental, utility, bioburden records; sanitization record; sterilization cycles.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 ophthalmic oil is filled into 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.The root cause of the reported complaint condition could not be determined.Potential root cause includes: solution quality issue: highly unlikely, as chemistry and microbiology data is reviewed and verified to meet regulatory requirements prior to release.Consumer mishandling: no conclusion can be made regarding the contribution of consumer mishandling as this factor is outside the control of the manufacturing facility.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.Surgical technique, product handling and storage are unknown.Lot specific evaluation is not possible without the lot code being reported.No further action is warranted 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: 11006356
• MDR Text Key: 221479957
• Report Number: 1610287-2020-00037
• 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: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR