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

Model Number	TFNT00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported following an intraocular lens implant procedure, patient was able to see distance but her close up was gone and also needed reading glasses for close up which she did not wear before but needed computer glasses and she still needed reading glasses with the lenses for computer.She had no night time vision at all anymore and it was not because of halos from the light.Additional information was requested and received stating left eye was blurry, lens turning colors in her eyes and being visible and moving around in her eyes.Lens was moving around in her eyes, also there were light reflections that made her look like a lizard in public, no night vision anymore could not drive anymore at night only in familiar area.Cloudy spot that she was seeing and said she had astigmatism and performed laser to the eye.Lying down watching tv or just looking her vision was totally blurry, then she had to close one eye and it goes one and off clean then not.Patient felt doctor gave the wrong prescription.Additional information was received stating symptoms were not resolved and patient was not hospitalized as a result of this events.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.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.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: 15697804
• Report Number: 1119421-2022-02307
• Device Sequence Number: 6707097
• Product Code: MFK
• UDI-Device Identifier: 00380652357685
• UDI-Public: 00380652357685
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.175
• Device Lot Number: 15307950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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 II IOL, CARTRIDGE B; MONARCH III IOL, INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female