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 Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient was unhappy with vision, patient stated that vision was blurry for distance and near, cannot see contrast and the vision at night was very bad with glare and halos.The iol was explanted in secondary procedure for different company lens.There was no patient harm, the surgeon prognosis was good, and patient was not hospitalized.No further information available.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The lens was returned inside a small plastic cup placed in a biohazard bag.Solution was dried on the lens.The optic was cut vertically into two pieces.The optic material splintered into cracks and splits along the line of damage.The optic edge of one optic portion was split.A power and resolution test could not be conducted on the returned lens due to being returned in pieces.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if a qualified combination of products were used with the lens.The root cause cannot be determined for the reported complaint.The lens was returned cut into pieces with additional damage.Each lens was 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 power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided in the file that the toric (2.25cyl add power +2.2/+3.2 ) 15.0 diopter lens was removed and replaced with a non-company lens (14.5 diopter).This information may suggest that the replacement lens model was an improved selection for the patient's vision needs or preferences.There are no other complaints in this lot.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: 14643743
• Report Number: 1119421-2022-01230
• Device Sequence Number: 5514411
• Product Code: MFK
• UDI-Device Identifier: 00380652419130
• UDI-Public: 00380652419130
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 06/30/2024
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.150
• Device Lot Number: 12724974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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: 72 YR
• Patient Sex: Female