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

Model Number	TFNT00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, while the product was being inserted, lens haptic broken.The broken part could not be found.Lens was explanted at initial procedure.The lens was replaced with unspecified lens, and post-operation irregular astigmatism occurred.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens.One haptic was broken in the gusset area.The broken haptic was not returned.The optic was cut from the edge, through the optic center, and toward the opposite edge of the optic.The optic damage was similar in appearance to damage created to facilitate a removal of the lens from the eye.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.Broken haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage 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.The optic was cut almost into two pieces.The optic damage was similar in appearance to damage created to facilitate a removal of the lens from the eye.It is unknown if qualified associated products were used.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu(instructions for use) instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The reported complaint included "irregular astigmatism" post surgery.The company 22.5 diopter (add power +2.2/+3.2 diopter) lens does not contain a cylinder component and would therefore not correct for astigmatism.Each lens is 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.Information was provided that the company 22.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with another lens.The replacement lens information was not provided.Follow up was conducted for additional information.The file indicated that all available information is already listed in the form.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 19078253
• Report Number: 1119421-2024-00667
• Device Sequence Number: 6695776
• Product Code: MFK
• UDI-Device Identifier: 00380652357784
• UDI-Public: 00380652357784
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.225
• Device Lot Number: 15616509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• Date Device Manufactured: 03/29/2023
• 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: Male