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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/04/2020
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 was one other complaint for this lot.There are two medical device reports associated with this patient.This report is associated with the left eye.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that following bilateral cataract extraction with intraocular lens (iol) implant procedures, vision is very blurry a year later.Vision is variable each day.Street signs are blurry and a magnifying glass is needed to read the newspaper.The consumer stated they had yag laser and touch up lasik in each eye following the initial implant procedure.The consumer is very dissatisfied.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information provided in a.3., b.3., b.5., and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided that the immediately after placement of the lenses on (b)(6) 2020, the astigmatism was not corrected.The doctor did yag laser which did not help.Later the touch up lasik was done on (b)(6) 2021, which corrected the residual astigmatism but the intermittent blurry and hazy vision continues.Doctor placed the punctual plugs on (b)(6) 2021, patient still having intermittent good and bad vision, and mostly bad.Some day¿s patient read newspaper and street sign and some days patient can't.Patients poor vision can't be corrected with glasses.Patient has not been diagnosed with macular edema, but is going on 10/28 for further testing.
Event or Problem Description
Additional information received stated that macula imaging was done which did not show edema.Ophthalmologist prescribed steroid medication four times daily.Which was tapered down to 2 times daily this week, 1 time daily next week and then stop.The medication did not made any difference to the vision.
Additional Manufacturer Narrative
All product and batch history records are quality reviewed prior to product release.Information was provided that the consumer had yag surgery, and later, touch up for lasik.Doctor also placed punctal plugs.Patient indicated still having intermittent vision issues.Patient did not wish to share doctors information but was scheduled for another doctors appointment to discuss issues.Additional information was provided that the patient saw ophthalmologist.It was reported that there was no macular edema.Doctor prescribed prednisone drops anyway with ni.Patient being referred to another ophthalmologist in spokane.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 ; 8175514979
• MDR Report Key: 12517992
• Report Number: 1119421-2021-01816
• Device Sequence Number: 14732995
• Product Code: MFK
• UDI-Device Identifier: 00380652418683
• UDI-Public: 00380652418683
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2021

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: 02/27/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.190
• Device Lot Number: 15050044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 11/15/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/15/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• 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
• Patient Sex: Female