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	Headache (1880); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
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 no other complaints reported in the lot number.(b)(4).
Event or Problem Description
A nurse reported that an intraocular lens (iol) was explanted approximately 4 months after implantation due to patient having headaches, trouble focusing and contrast photophobia.Additional information was requested.
Additional Manufacturer Narrative
Information was provided that a qualified cartridge and viscoelastic were used.The handpiece information was not provided.Without the handpiece information, it is not possible to determine if a qualified product combination was used.Based on information provided on the completed questionnaire, the root cause of the reported complaint was determined to be unrelated to the lens.The event was indicated to be bilateral.The cause of this outcome was explained by the doctor to be the "patient¿s pupils did not work well with iol." the (1.50 cyl) 15.0 diopter lens was removed and replaced.The replacement lens model and diopter information was not provided.The doctor explained that the patient's issues have resolved after the iol exchange and the prognosis is excellent.This information also supports that the replacement lens was a better selection for this patient's anatomy and vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating the patient experienced glare, unable to drive at night and unable to read at near.The patient¿s pupils did not work well with iol.The patient's symptoms were resolved post lens exchange.
Additional Manufacturer Narrative
Based on information received following submission of the follow up report, this event does not meet criteria for reporting as a serious injury.Based on information provided on the completed questionnaire, the root cause of the reported complaint was determined to be unrelated to the lens.The event was indicated to be bilateral.The cause of this outcome was explained by the doctor to be the "patient¿s pupils did not work well with iol".The multifocal toric lens model (1.50 cyl) 15.0 diopter was removed and replaced with an monofocal toric lens model (1.50 cyl) 15.0 diopter.The doctor explained that the patient's issues have resolved after the iol exchange and the prognosis is excellent.This information also supports that the replacement lens was a better selection for this patient's anatomy and vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that the patient was replaced with monofocal lens with same diopter.There is no reported defect or fault with the iol.

• 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: 13416712
• Report Number: 1119421-2022-00147
• Device Sequence Number: 11934636
• Product Code: MFK
• UDI-Device Identifier: 00380652418607
• UDI-Public: 00380652418607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2022

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: 03/06/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.150
• Device Lot Number: 15153095
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 01/21/2022; 02/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/11/2022; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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: MONARCH III CARTRIDGE D.; MONARCH III CARTRIDGE D.; PROVISC OVD.; PROVISC OVD.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male