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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 health care professional reported that, following the intraocular lens (iol) implant procedure the patient had vision problems.The patient¿s left eye is the worst and don't know if its the surgeon or the lens.Additional information received and stated that, the patient had a second opinion for fear that, was going to go blind but the physician has assured me that patient sight should not deteriorate much more than it has and he sees no signs of blindness.The patient says brochure is nothing like the results.The patient doesn¿t has distance vision as well as was suggested, and have inferior mid range and close up vison.The night vison is far worse than expected.The patient has halo and starring around all the lights along with vison not any better than it was, night driving is very difficult and i can barely drive anywhere.The patient says, have lost my desire to do some of the things patient used to enjoy.Shopping and trying to see is worse than it was before surgery.Watching grandson play baseball through a fence or basketball in an gym gives trouble because it¿s a depth problem that if hard to comprehend.The eye surgeon said he could try to remove them but could not guarantee results.The second opinion doctor said not to have that done unless it was done by one particular doctor that corrects problems with these lens.The eye surgeon has apologized numerous times and even provided glasses that are not the solution.The surgeon has refunded a partial amount of the cost and said they just didn¿t work for me.
Additional Manufacturer Narrative
The product was not returned.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.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: 16855229
• Report Number: 1119421-2023-00813
• Device Sequence Number: 20747882
• Product Code: MFK
• UDI-Device Identifier: 00380652357746
• UDI-Public: 00380652357746
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/02/2023

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: 11/17/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.205
• Device Lot Number: 15116654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Unknown