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

Catalog Number	8065900163
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that they experienced the single drop dispensing as multiple drops for the perfluoron kit due to air/gas in device.The patient had a vision problem (unknown eye) and required intervention.
Additional 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).
Additional Manufacturer Narrative
Review of the complaint history shows no similar complaint reported.Review of the 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 (quality assurance) 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 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 will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: PERFLUORON
• Common Device Name: 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: 15411694
• Report Number: 1610287-2022-00066
• Device Sequence Number: 20243953
• Product Code: LWL
• UDI-Device Identifier: 00380659001635
• UDI-Public: 00380659001635
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P950018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 8065900163
• Device Lot Number: 10PV0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown