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

Model Number	TFAT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the lens was explanted in a secondary procedure due to patient preference.Additional information has been requested.
Additional Manufacturer Narrative
The product was 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).
Event or Problem Description
Additional information was received stating the patient did not like the quality of vision with the company lens and said vision was dim.Patient was not hospitalized for the event and there was no patient harm.The patient issues were resolved.
Additional Manufacturer Narrative
The explanted lens was returned inside a small plastic envelope placed in a specimen jar.One broken haptic was returned.This haptic was cut in the haptic/optic junction.Only a large cut portion of the explanted optic was returned.The optic has linear cracks on the anterior and directly opposite on the posterior in the shape of an instrument used to grasp the lens.The power and resolution of the returned lens could not be re-evaluated due to only a portion of the optic was available to test.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece were used.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.Only one haptic and a cut portion of the explanted optic were returned.The power and resolution of the returned lens could not be re-evaluated due to only a portion of the optic was available to test.During the manufacturing process, each lens is subjected to a 100% assessment of the power and optical resolution in order to determine acceptability per the lens model and diopter.Information was provided in the file that the explant was conducted due to patient preference.The multi-focal toric 20.5 diopter lens was removed and replaced with a non-company, non-toric, monofocal, 20.5 diopter lens.This information reasonably suggests that the replacement lens model was a better selection for the patient's vision needs or preferences.Based on the information provided that the multifocal toric lens was replaced with a monofocal non-toric lens, this complaint was most likely not related to a quality issue with the lens.Additionally, a failure to follow the ifu occurred with the use of a non-qualified viscoelastic.The damage to the lens may have been exacerbated by the use of the non-qualified viscoelastic in the cartridge.The ifu instructs that a 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.Company recommends using the qualified delivery system or any other company qualified combination.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: 14405399
• Report Number: 1119421-2022-01041
• Device Sequence Number: 11370096
• Product Code: MFK
• UDI-Device Identifier: 00380652419772
• UDI-Public: 00380652419772
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 10/31/2024
• Device Model Number: TFAT50
• Device Catalogue Number: TFAT50.205
• Device Lot Number: 12756731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female