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	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The lens was cleaned with klrp for further evaluation.The optic had scratches and cracks on the anterior and posterior sides of the lens.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The root cause could not be determined for the reported ¿defective lens¿ complaint.The specific lens issue was not specified.Damage to the lens was observed.While we are unable to determine the root cause of the lens damage, our observation reasonably suggests that it is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Associated products were not provided.It is unknown if qualified products were used.Company foldable iols are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.No further information has been provided at this time.Follow up attempts were made for more details of the event.No additional information has been provided at this time.File will be reopened when more information is received.The manufacturer internal reference number is: 2024-03118.
Event or Problem Description
A facility representative reported with a description of defective intraocular lens (iol).Additional information has been requested.

• 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: 18639525
• Report Number: 1119421-2024-00204
• Device Sequence Number: 7763067
• Product Code: MFK
• UDI-Device Identifier: 00380652418751
• UDI-Public: 00380652418751
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.225
• Device Lot Number: 15213816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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
• Patient Sex: Unknown