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

Model Number	TFNT00
Medical Device Problem Codes	Application Program Problem: Power Calculation Error (1473); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Irritability (2421)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient has a very good postoperative result and unfortunately he is not satisfied.Post operatively seven months patient had constant contrast deficit (seeing as if through a thin wax wick) and dim head feeling, constant blurred vision in the extended near range, constant, unsatisfactory perception of the environment in artificial, especially dim lighting (as if intoxicated), constantly extreme halos when working with digital output devices, such as smartphones, notebooks, etc.(backlighting), reading magazines/books only possible in (bright) daylight for a short time (< 30 minutes) (problem: concentration problems, eye flicker), no depth perception under artificial illumination at close range (e.G., mold on food is often not detected!), postoperative, higher light sensitivity, glare unpleasant especially with reflected light on metal surfaces, frequent dull (head) heaviness and early fatigue (unusual need for sleep already at midday), often irritated (dry) eyes (drops bring relief), only silhouette perception in backlight (faces not perceptible).The patient also visited post operatively 11 months and stated that, patient has constant contrast deficit/ lack of depth perception / veil vision in the entire visual range, at least when using reading glasses, the contrast deficit at close range is practically eliminated, while watching television (tv) sharpness has deteriorated - improvement with extreme head tilt and upward gaze, constantly extreme halos when working with digital output devices, such as smartphones, notebooks, etc.But there was exception while using the reading glasses, reading of magazines / books due to contrast deficit only possible for a longer time in (bright) daylight and use of reading glasses, higher (acceptable) light sensitivity, glare unpleasant especially with reflected, artificial light at close range on metal surfaces.Improvement through use of reading glasses.The patient also stated that, only occasional need for lubricant eye drops, also he had silhouette perception in special lighting conditions (faces / facial expressions not recognizable).The patient was stated 11 months after surgery symptoms unchanged.The surgeon had discussed with the patient about, clarification of possible options, the patient decides to replace the multifocal lens with another model lens.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5., d.4., d.6.B, h.4., and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the lens was replaced with another lens.The 16.5 lens was exchanged for a different model 17.0 lens.
Additional Manufacturer Narrative
Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.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 hcp provided the information that the patient had a very good postoperative result, but unfortunately was not satisfied.The company 17.0 diopter (add power +2.2/+3.2) lens was replaced with a company 015, 17.0 diopter extended 1.5 diopters of focus) lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 16311805
• Report Number: 1119421-2023-00252
• Device Sequence Number: 6185103
• Product Code: MFK
• UDI-Device Identifier: 00380652357661
• UDI-Public: 00380652357661
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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: 12/07/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.165
• Device Lot Number: 15118516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/25/2023; 03/28/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/21/2023; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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; Other
• Patient Sex: Male