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

Model Number	TFNT30
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the implantation of intraocular lens (iol) patient experienced halos and glares at night that are so bad and traffic signage was blurry.The patient could not read signs until near.The optometrist told that the left lens shifted after surgery.Additional information has been received and patient had rim and pulses at the corner of the eye when looked to left and signs are hard to make out until right under them.The patient do not drive at night as she sees glares and halos and blurry signs at night, but to a lesser degree in the daytime.The ophthalmologist did a pinhole test which cleared up the distance blurriness.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 15713223
• Report Number: 1119421-2022-02333
• Device Sequence Number: 4800954
• Product Code: MFK
• UDI-Device Identifier: 00380652389976
• UDI-Public: 00380652389976
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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: TFNT30
• Device Catalogue Number: TFNT30.200
• Device Lot Number: 15295989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female