MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following the intraocular lens (iol) implant procedure the patient states it looks like she is looking through oil and has flickering.The iol was replaced with a non-company lens in a secondary procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned cut into two portions returned on a piece of medical sponge in a plastic bag.Viscoelastic was observed dried on the lens.The lens was cleaned with klrp to further evaluate.The lens was allowed to air dry.After drying, the lens appeared clear.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 and resolution of the returned lens could not be re-evaluated due to the optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and a company handpiece.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.The explanted lens was returned cut into pieces.The lens appeared to be clear.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 and resolution of the returned lens could not be re-evaluated due to the optic damage.The instruction for use (ifu) instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company 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 file indicated that the company lens (1.50 cyl.) 20.0 diopter (add power +2.2/+3.2 diopter) was removed and replaced with a non- company lens ( ic-8 apthera 23.0 diopter).This information that a company lens 20.0 diopter lens was exchanged for a non- company lens (ic-8 apthera extended depth of focus lens) with a 3 diopters difference suggests that the replacement lens model and diopter was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 17378936
• Report Number: 1119421-2023-01318
• Device Sequence Number: 20379107
• Product Code: MJP
• UDI-Device Identifier: 00380652457385
• UDI-Public: 00380652457385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 06/28/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.200
• Device Lot Number: 15440939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/24/2023
• Date Device Manufactured: 06/30/2022
• 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: IC-8 APTHERA 23.0 DIOPTER, SN: 60178680; MONARCH INJECTOR; MONARCH CARTRIDGE C; OCCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female