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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.Lens was explanted during secondary procedure.Lens was replaced with unspecified lens.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.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
The lens was returned in a specimen cup.Viscoelastic and yellow colored clinical solution was observed on the lens.The optic was scratched along the anterior surface from near the optic edge, travelling across the optic rings toward the optic center.The optic was cracked and gouged near the anterior optic center.The lens was cleaned with klrp for further evaluation.The posterior optic surface has two cracked areas around the central optic zone.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if a qualified combination of products were used with the lens.The root cause for the reported complaint of blurred vision cannot be determined.The explanted lens was returned with damage to the anterior and posterior optic.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the clinical reason for explant was "mechanical complications".However, it was noted in the file that the iol does not have a mechanical component--the terminology used to report mechanical complication is an insurance coding term that is used for billing and coding when a lens is exchanged---the verbiage does not indicate a lens malfunction.The replacement lens information was not provided.Follow up attempts were made for additional information.No further information has been provided.If additional information becomes available, the file will be reopened and updated.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18214113
• Report Number: 1119421-2023-02024
• Device Sequence Number: 6613279
• Product Code: MFK
• UDI-Device Identifier: 00380652418690
• UDI-Public: 00380652418690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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: 06/29/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.195
• Device Lot Number: 15080655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• 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: Required Intervention
• Patient Sex: Unknown