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

Model Number TFAT00

Device Problem Application Program Problem: Power Calculation Error (1473)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

The lens was returned for evaluation.Solution is dried on the lens.The lens was cut in half, typical of insertion and removal from the eye.Scratches are observed on the optic portions of the lens.All product and batch history records are quality reviewed prior to product release.The file indicates the use of an unspecified cartridge, a non-qualified handpiece, and non-qualified viscoelastic.The root cause for the reported events could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.The company, 20.0 diopter (add power +2.2/+3.2) lens was replaced with a company 21.0 diopter (add power +2.2/+3.2) lens.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced having difficulty focusing.The iol was exchanged for another lens model 4 months following the initial implant procedure.The clinical reason for explant mentioned as negative dysphotopsia.Additional information received and stated that the patient was not hospitalized for the event and there was no patient harm.

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL
• Type of Device: 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: 15264270
• MDR Text Key: 298279003
• Report Number: 1119421-2022-01816
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.220
• Device Lot Number: 15308027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: B&L OCUCOAT OVD; BARRETT; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male