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

Model Number	TFAT30
Medical Device Problem Codes	Material Opacification (1426); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137)
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.There have been 2 other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision close and far, not happy and also laser after the surgery.Additional received and stated that the patient experienced cloudy both near and far, hard to see and also not really floaters but like always looking through a fog.There are two medical device reports associated with this patient.This report is associated with file 1 of 2.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the patient was trying a/r coated glasses and considered another opinion on the issue.
Additional Manufacturer Narrative
No change to the root cause or malfunction determination.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating physician tried eye drops for pupils and dryness.Patient tried driving glasses but nothing helped.
Event or Problem Description
Additional information received from consumer stating the surgeon saw crystallization of both the lens that were put in and the lens will be explanted.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received from consumer stating the lens was scheduled to explant the lens earlier but failed to do so due to the eye issues.The surgeon has explanted the lens and replaced with a monofocal lens later.The reason for explant was glistening's and it compromised the vision clarity.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned submerged in clear liquid in a plastic specimen jar.The lens was removed from the liquid and allowed to air dry.Solution patterns were observed on the lens upon drying.The haptics are undamaged.The lens was cleaned with klrp to remove the dried solution patterns present on the lens.The optic has very small, light scratches observed across the anterior optic outer rings.The lens was allowed to acclimate to room temperature prior to further evaluation.After acclimation to temperature, there was no visible evidence observed of glistenings within the lens.Small microscopic embedded particles were observed near the optic edge.This cosmetic imperfection was acceptable per current release criteria and would not impact the functionality of the lens.It is unknown if the embedded particles were interpreted as the complaint.A power and resolution verification of the returned lens was conducted by engineering and the lens met specification for a trifocal 20.5 diopter lens.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.The root cause cannot be determined for the reported complaint.The explanted lens was returned submerged in liquid.The lens was cleaned, allowed to air dry and allowed to acclimate to the room temperature.The optic has light scratches across the optic rings.There was no visible evidence of glistenings within the lens material.Minute microscopic embedded particles were observed near the optic edge.It is unknown if the embedded particles were interpreted as the complaint.The presence of this cosmetic imperfection would not have an impact on the functionality of the lens.This cosmetic imperfection meets current release criteria.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.The reporter was the patient.Information was provided by the patient that issues with blurriness focus occurred about 6 months after implants.Doctor did laser both eyes, tried eye drops for pupils and dryness.Tried driving glasses.Nothing helped.The hcp provided information that the lens was implanted on (b)(6) 2020.The hcp was made aware of the complaint on 17-jan-2022.The hcp indicated the cause of the issues is unknown.Second and third opinions were sought by the consumer.A surgeon explanted the lens.The trifocal toric (1.50 cyl) 20.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a monofocal 21.5 diopter lens.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: 15812495
• Report Number: 1119421-2022-02434
• Device Sequence Number: 17925445
• Product Code: MFK
• UDI-Device Identifier: 00380652418713
• UDI-Public: 00380652418713
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.205
• Device Lot Number: 12716813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 02/23/2023; 04/12/2023; 02/06/2024; 03/11/2024
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/15/2022; 03/20/2023; 05/07/2023; 03/01/2024; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• 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: PROVISC OVD.; VISCOAT OVD.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown