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

Catalog Number 8065900113

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Retinal Detachment (2047)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

No sample has been received at 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 fourth of five reports for this reported event.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that when the silicon oil (so) was replaced from perfluoro-n-octane liquid (pfc) in a combination cataract and vitrectomy surgery, the viscosity of silicon oil increased and could not be removed rather, it remained on and migrated under the retina after which the treatment for the rhegmatogenous retinal detachment with the giant tear could not be completed.The surgeon reportedly replaced the perfluoro-n-octane with silicon oil while adding irrigation solution.In that environment, the silicon oil headed over the irrigating solution, causing turbulence in the eye and redetachment of the treated detached retina.The surgeon tried to remove the silicon oil, but it was so viscous that he could not remove it in the back of the eyeball with a backflush needle.He punctured the pars plana with a knife and removed it with a 22g catheter needle, but the oil could not completely removed.An ophthalmic gas, sulfur hexafluoride, was then used and the surgery was completed.The surgery time which was planned for about 90 minutes, was extended to four hours.The patient was transferred to the another hospital for an additional surgery.Additional information has been requested.Additional information received clarified that cataract portions of surgery were performed as usual, a 27g three port was placed and fluid/air exchange was performed.The retina of the giant tear on the superior nasal side was slipped.Perfluoro-n-octane liquid was injected to the bottom of the tear margin during the performed procedure.When silicon oil was injected and the water layer was aspirated with a backflush needle, the perfluoro-n-octane was directly substituted with silicon oil.Once the silicon oil was removed, a mass of silicon oil remained on the retina that did not come upward.It was finally removed by inserting the outer tube of a 22g needle through the perforation wound from a knife and connecting it to viscous fluid control (vfc) aspiration.The sulfur hexafluoride gas was further confirmed to have been used at 20% concentration.Retinal detachment improved with continued prone position.Additional information received further clarified that it was not confirmed if the silicon oil and perfluoro-n-octane liquid remained in the affected eye.The detached retina resolved and post-operative patient condition was good, as a result, a re-operation was not performed.

Manufacturer Narrative

Review of the complaint history shows no similar complaint reported.Review of the manufacturing batch record (mbr) record of the lot number provided indicated that product was processed and released according to the product's acceptance criteria.Review of the incoming component qa inspection reports showed to be acceptable.All finished product testing results met specifications.The product is manufactured according to requirements of the perfluoro-n-octane device master record.The product is sterilized via filtration through sterilized silastic tubing filled into dry heat sterilized vials using a peristaltic pump.Finished product testing includes infrared adsorption, ultrafiltration absorption, purity of perfluoro-n-octane (pfno) (gas chromatography), particulate analysis, bioburden and sterility.All testing for the batch associated with the reported lot met specifications.The product insert provides indications, instructions, and storage condition.Customer product storage and use could not be confirmed.The product labeling for perfluoro-n-octaneprovides 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¿.Root cause could not be determined.Potential root causes include: solution quality issue ¿ unlikely, as chemistry and microbiology data was reviewed and was found to have met 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.Event related to consumer physiology ¿ no conclusion can be made regarding the contribution of unique consumer physiology as this factor is outside the control of the manufacturing facility.Surgical practices cannot be confirmed, (e.G.During injection, etc.).A comprehensive review was performed including review of the mbrs, complaint history, sanitization records, bioburden records, stability data, incoming component inspection results, in process finished products and environmental/utility samples.The review shows that the manufacturing processes were in a state of control.Based on acceptable mbr review, incoming component qa inspection testing results, and finished product inspection results, this lot continues to be acceptable.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: 12274046
• MDR Text Key: 264953851
• Report Number: 1610287-2021-00022
• 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
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065900113
• Device Lot Number: 105Y1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR