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

Model Number	TFNT60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Scar (1793); Scar Tissue (2060); Vertigo (2134); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).
Event or Problem Description
A health professional reported that after an intraocular lens (iol) implant surgery, the patient is experiencing scarring behind the lens, scarring on the surface of the eye, blurred vision, visual imbalance and vertigo.The patient is required to wear special glasses due to the imbalance in vision.The surgeon stated the removal of the lens is not an option due to high risk of total blindness.Additional information has been requested.
Additional Manufacturer Narrative
One photo was provided for this case.The non-slit lamp photo is of the general orbital area and the iol is not visible.Therefore a photo review is not possible for this case.A non-qualified cartridge/iol combination was indicated.The diopter lens is not qualified for use with the cartridge.The qualified diopter range for this lens model is 6.0- to 25.0 diopters.Root cause: the product investigation could not identify a root cause for the reported event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating i was told i have scarring behind this lens, and have attached an ir photo of the surface of my eye and how it reacted to the implant, requiring two more surface/removal surgeries by doctor peabody.The surface was cleared up by the two additional surface surgeries and has resolved that issue.Was told the scar behind the implant was too risky to remove, that it could just scar again, and that it was not possible to see if the lens was placed improperly, or if it has shifted, due to scarring around the lens.Told removing or replacing lens, not an option, as risks total blindness.I am on the 5th pair of glasses to correct imbalance between the eyes now, have had severe vertigo, unable to read, and need r eye cataract removed as well.Latest script is allowing some reading, corrected most of horizon line issue, and still have some vertigo.You can imagine i am totally reluctant to have the r eye cataract removal with this previous ordeal.I am submitting this and willing to help you sort this out, so no one else has to go through this.Thank you for this effort to find out what went wrong.You should also know i have multiple auto immune issues and that may have contributed to my response to a lens implant.

• 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
• MDR Report Key: 11560521
• Report Number: 1119421-2021-00634
• Device Sequence Number: 4183213
• Product Code: MFK
• UDI-Device Identifier: 00380652417280
• UDI-Public: 00380652417280
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2021

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: 04/30/2024
• Device Model Number: TFNT60
• Device Catalogue Number: TFNT60U285
• Device Lot Number: 12712938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 05/19/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/05/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH CARTRIDGE D; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Other