MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT40
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis will be completed.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 or Problem Description
A facility representative reported following the intraocular lens (iol) implantation, the patient had experienced cloudy vision and there were deposits on posterior surface of iol.The patient is also scheduled for a planned explant.Additional information was received that the lens was explanted in a secondary procedure with no harm to the patient.The patient was not hospitalized as a result of the event and the prognosis was good.The surgery was completed by using a replacement lens.
Additional Manufacturer Narrative
The lens was retuned in a specimen cup.Solution and what appears to be blood was dried on the lens.The optic was cut into pieces, typical of insertion and removal.The cut optic portions had nick/chips and cracks on the anterior and posterior sides of the optic.This damage may have been interpreted as the reported "deposits on posterior surface of iol".Power and resolution testing could not be conducted, due to the extensive optic damage.Complaint history and product history records were reviewed, and the documentation indicated, the product met release criteria.A qualified company handpiece was indicated.The file indicated, the use of a non-qualified viscoelastic.The associated cartridge was not provided.It is unknown, if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted, due to the extensive optic damage.The power and resolution of each lens is 100% evaluated, during the manufacturing process to determine acceptability, per model and diopter.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12437858
• Report Number: 1119421-2021-01705
• Device Sequence Number: 4739147
• Product Code: MFK
• UDI-Device Identifier: 00380652419406
• UDI-Public: 00380652419406
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2025
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.285
• Device Lot Number: 15032391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL INJECTOR; OVD:HEALON; MONARCH III IOL INJECTOR; OVD:HEALON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR