MAUDE Adverse Event Report: ALCON RESEARCH, LLC PERFLUORON; FLUID, INTRAOCULAR

Catalog Number 8065900113

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/21/2020

Event Type  Injury  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.Investigation including root cause analysis is in progress.This is the first of two reports for this reported event.The manufacturer internal reference number is: 2020-50847.

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.

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 a.1, a.2, a.3, b.3, b.5, d.10, e.1, h.3, h.6 and h.10.A sample has been received at manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).

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.The swab was visually and 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 silicone and perfluoro-n-octane products were used in the procedure.All compounding, preprocessing, filling and packaging mbrs are subjected to 2 independent reviews.- all chemistry and microbial finished product results - environmental, utility, bioburden records, and - sanitization records at a minimum, a single normal level-1 particulate inspection is completed for each lot and a level i iba is performed for every lot manufactured.This product is terminally sterilized and all sterilization cycles are reviewed before product is released.Primary components are reviewed by qa before release to production.Perfluoro-n-octane is supplied in 2 ml, 5 ml and 7 ml vial sizes.Each vial is aseptically processed and supplied in an individual blister package sterilized with steam, providing a finished product vial with a sterile exterior.The vial is provided in a ready to use sterile kit that includes a cannula, microbial filter, luer-lok syringe and needle.The sterile kit is placed in a protective box together with labels and product information.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.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: PERFLUORON
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 10570184
• MDR Text Key: 208088096
• Report Number: 1610287-2020-00024
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• PMA/PMN Number: P950018
• 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: 8065900113
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• 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