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

Model Number	TFAT30
Medical Device Problem Codes	Material Opacification (1426); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure the lens found to be is cloudy, so surgeon suggested to exchange the iol.Additional information has been requested.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned submerged in clear liquid in a plastic specimen cup placed into a large biohazard bag.The lens was cut into pieces, typical of damage created to remove a lens from the eye.The lens portions were removed and allowed to air dry prior to evaluation.Upon drying, the lens did not appear cloudy.The optic has a deep scrape mark from the optic edge toward the optic center and additional scratches.It is unknown if the lens damage was misinterpreted as the reported complaint.Information was provided that a qualified cartridge and qualified viscoelastic were used.The handpiece information was not provided.It is unknown if a qualified handpiece was used.The root cause cannot be determined for the reported complaint of "lens is cloudy, explant".The lens was returned in pieces, typical of damage created to help remove a lens from the eye.After removal and drying of the lens, the lens did not appear to be cloudy.The optic portions had a deep scrape and scratches.It is unknown if the optic damage was misinterpreted as the reported complaint.Each lens was 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 power, cylinder and resolution of the returned lens could not be re-evaluated due to the optic damage.It is unknown if a qualified handpiece was used for this lens/cartridge/viscoelastic combination.The ifu instructs: alcon foldable iols are qualified for use with an alcon qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an alcon qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING 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: 18031446
• Report Number: 1119421-2023-01839
• Device Sequence Number: 6074479
• Product Code: MFK
• UDI-Device Identifier: 00380652418676
• UDI-Public: 00380652418676
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.185
• Device Lot Number: 15050144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON IOL; DUOVISC; MONARCH III CARTRIDGE C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male