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

Catalog Number 8065900111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Retinal Degeneration (2049); Visual Impairment (2138)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that perfluoro-n-octane was used in macular surgery of a patient.The patient experienced macular atrophy after the surgery.Additional information has been requested.Additional information has been received indicating that the surgery was a combined vitrectomy procedure and locoregional anesthesia was used.

Manufacturer Narrative

No sample has been received for evaluation.Review of the complaint history shows no similar complaint reported.Review of the manufacturing batch record (mbr) 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 (reference the component grid for lot code).All finished product testing results met specifications.The product is manufactured according to requirements of the 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, uf absorption, mnr, purity of 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.Root cause for the complaint condition could not be determined.Potential root causes include: ¿ solution quality issue ¿ highly unlikely, as chemistry and microbiology data are 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.¿ 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.¿ event related to surgical technique ¿ no conclusion can be made regarding the contribution of surgical technique.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 will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a patient with macular atrophy and severe vision affectation post-op a vitreo-retinal procedure (vitrectomy + laser + gas).The surgeon indicated wanting to "discard the potential toxicity" for the reported suspected product used in the procedure.A product sample for the suspected product was requested for evaluation, however, the reporter indicated that there was no product sample available as it was completely used during the surgery.

• Brand Name: PERFLUORON
• Type of Device: FLUID, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13677665
• MDR Text Key: 286637558
• Report Number: 1610287-2022-00018
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P950018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 8065900111
• Device Lot Number: 10KRC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male