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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that an intraocular lens (iol) implant procedure was not successful as depth of focus multifocal lens was recommended despite, what she had since learned with her new doctor was there being two contraindications that actually meant she was not a candidate for said lens.Additional information has been requested, received and stated the consumer had history of retinal detachment (rd) w/ repair to other eye prior to cataract surgery as well as lattice degeneration.She stated due to the rd repair her pupil does not constrict or dilate normally.She sees fuzzy in all distances.Lines were not straight but isn't sure if that's from the rd repair or from the implants.She had yttrium aluminum garnett (yag) posterior capsulotomy.Patient now has to wear glasses to correct vision.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The product 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 product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not indicated.The product investigation could not identify a root cause for the reported complaint.The lens remained implanted.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Follow up attempts were made for additional information.The file indicated that the patient has a history of rd (retinal detachment) with repair in the bilateral os eye prior to cataract surgery, as well as lattice degeneration in both eyes.The patient stated that yttrium aluminum garnett (yag) was conducted for both eyes.Contraindications and the visual results were discussed with the patient.The patient stated that due to the rd repair (os), her pupil does not constrict or dilate normally in the left eye.The patient described the visual symptoms, but isn't sure if the visual issues were from the rd repair in the bilateral (os) eye, or from the implants.The patient discussed further and stated that she is not interested in an intraocular lens (iol) exchange.Also due to the history, the patient may not be a candidate.Patient now wears glasses to correct her vision.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 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: 18667248
• Report Number: 1119421-2024-00217
• Device Sequence Number: 20938589
• Product Code: MFK
• UDI-Device Identifier: 00380652415323
• UDI-Public: 00380652415323
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 09/30/2024
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30U100
• Device Lot Number: 12750531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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: 41 YR
• Patient Sex: Female