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

Model Number	TFAT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned inside a self sealing, non company pouch placed into a plastic bag with a biohazard sticker.The lens was removed for evaluation.The optic was cut into pieces, typical of a removal from the eye.One haptic was cracked on the distal anterior surface.The other haptic was scraped along the inner distal edge.One optic portion edge was broken.The broken optic material was not returned.This optic portion also has a line of cracked damage in the shape of an instrument used to hold the lens.The damage was present on the anterior and directly opposite on the posterior optic surface.The other optic portion has a long scratch across the optic rings.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece was used with a non-qualified viscoelastic.The root cause cannot be determined for the reported complaint.Each lens was subjected to a 100% assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the patient was not adapting to current iol.The multifocal company ( 2.25 cyl.) 17.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal lens, 18.0 diopter.The information of exchanging a multifocal lens for a monofocal lens may suggest that the replacement lens (monofocal) may have been an improved selection for this patient's vision needs.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implant procedure, the lens was explanted and exchanged with another lens model following the initial procedure.Clinical reason for explant was mentioned as patient not adapting to current iol.
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information provided in d.9.And h.3.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: 19979309
• Report Number: 1119421-2024-01565
• Device Sequence Number: 12797212
• Product Code: MFK
• UDI-Device Identifier: 00380652419185
• UDI-Public: (01)00380652419185(17)240930(11)191026(10)12740796
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: TFAT40
• Device Catalogue Number: TFAT40.175
• Device Lot Number: 12740796
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2019
• 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: DIU15018.0, SN (B)(6).; HEALON.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown