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

Model Number	TFNT50
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The lens was returned positioned incorrectly in the lens case.One haptic was broken in the gusset and distal area (haptic portion returned on top of optic).The optic was extensively damaged into multiple pieces.The pieces are on top of each other and located down in the well area of the lens case.One portion was also pressed against a post.The damage appears to caused by the posts and the lid of the lens case.The returned sample matches the photos attached to the file.Lens damage was observed.The returned sample exhibited no evidence of customer handling.The lens damage appears to have been caused by the posts and the lid of the lens case.If the lens becomes misaligned in the lens case, lens damage may occur.Information was provided that after the reported damaged company lens (3.00cyl), 21.5 diopter (add power +2.2/+3.2) was noticed, the doctor implanted a monofocal lens as a placeholder and one day later exchanged that lens with a new company lens (3.00cyl), 21.5 diopter (add power +2.2/+3.2).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported during an intraocular lens (iol) implant procedure, the lens appeared deformed in the box hence monofocal lens was implanted, one day later monofocal lens exchange was performed with a newly ordered trifocal lens.Additional information was requested.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 17315533
• Report Number: 1119421-2023-01254
• Device Sequence Number: 4057863
• Product Code: MFK
• UDI-Device Identifier: 00380652391108
• UDI-Public: 00380652391108
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Model Number: TFNT50
• Device Catalogue Number: TFNT50.215
• Device Lot Number: 15477290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Date Device Manufactured: 08/22/2022
• 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 Age: 52 YR
• Patient Sex: Female