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

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.

Manufacturer Narrative

Additional information is provided in sections a.1, a.2, a.3, b.3, b.5, e.1 and h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received further clarified that the intervention procedure performed was a pars plana vitrectomy surgery to the left eye at which time subconjunctival foreign materials of perfluoro-n-octane liquid and silicone oil were removed.It was further clarified that the previous report of subconjunctival hemorrhage is now understood to be strong hyperemia.The patient's current status is presently reported as improving.

Manufacturer Narrative

Additional information is provided in sections h.6 and h.10.No lot code was reported by the customer therefore, lot specific evaluation cannot be completed.A swab was returned and sent to the particulate lab for companion file qs1642424.The swab was visually an microscopically examined and the presence of the foreign material was confirmed.Microscopic examination shows an opaque material.It was observed the material was comprised of two different components.Comparison of the opaque material generated infrared spectra to a library of spectra finds the closest match to be skin tissue and the other oily substance closest match to be poly(dimethylsiloxane).Polydimethylsiloxane, also known as dimethylpolysiloxane or dimethicone, belongs to a group of polymeric organosilicon compounds that are commonly referred to as silicones.Polydimethylsiloxane is the most widely used silicon-based organic polymer due to its versatility and properties leading to many applications.Both silicon and perfluoro-n-octane were used in the procedure.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 records.- sterilization cycles.The manufacturer's silicone oil product 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 product is filled into 10 ml 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.It was noted that there was a period of 3 months between the surgery and the removal of the foreign material from the patients eye.The root cause of the complaint condition could not be determined.Potential root cause includes: ¿ solution quality issue ¿ 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 product 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 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: 10570357
• MDR Text Key: 208088492
• Report Number: 1610287-2020-00025
• 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
• 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 Received: 09/22/2020
• 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: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR