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

Model Number TFNT00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Visual Impairment (2138); Distress (2329)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported regarding a customer who had a surgery of "trifocal iol".The customer stated that since her surgery she has no reading vision and extremely poor distance vision.Seeing tv about 8 feet was good.She had been told by her surgeon there everything was perfect.Customer stated she wants other options and she was not willing to "live with it".The customer submitted still no reading vision after 4 months and driving vision was poor.Good vision at 8 feet.No change in any vision distance since day of surgery.Surgeon says everything is perfect, but near vision is non functional, distance vision is poor.She needs good vision (especially for reading).She asked regarding options.She had been using the left eye, she also had a cataract in that eye and she was afraid that when it gets bad enough to require surgery she would not be able to read at all.She was scared.Additional information has been requested.

• Brand Name: ACRYSOF IQ PANOPTIX 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 ; 8175514979
• MDR Report Key: 10968814
• MDR Text Key: 220223943
• Report Number: 1119421-2020-01870
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2020

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
• Device Operator: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00_XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other