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 Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the lens was explanted and replaced with monofocal lens in a secondary procedure.The clinical reason for the explant was mechanical complication.Additional information was requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned in a plastic specimen jar inside a large biohazard bag.Solution was dried on the lens.One haptic was split on the haptic or optic junction edge and broken in the distal area still attached.The optic was cut from edge through optic center almost to the opposite edge of the lens.The anterior optic was scuffed.The posterior optic surface was cracked and scratched.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The root cause cannot be determined for the reported complaint of mechanical complaint explant unknown reason.A specific malfunction was not alleged.The follow up details indicated that the iol does not have a mechanical component the terminology used to report mechanical complication is an insurance coding term that is used for billing and coding when a lens is exchanged the verbiage does not indicate a lens malfunction.The explanted lens was returned cut almost into two pieces with additional lens damage observed.The cut damage was similar in appearance to damage from insertion and removal.Each lens was subjected to a 100percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power sphere and cylinder and resolution of the returned lens could not be re evaluated due to the optic damage.Information was provided that the company model (1.50 cylinder) 21.0 diopter (add power plus2.2 by plus3.2 diopter) lens was removed and replaced with a monofocal.The specific model and diopter of the replacement lens was not provided.The information that a multifocal toric lens was removed and replaced with a monofocal would suggest that the replacement lens 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: 19458710
• Report Number: 1119421-2024-01062
• Device Sequence Number: 6652969
• Product Code: MJP
• UDI-Device Identifier: 00380652457408
• UDI-Public: 00380652457408
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 02/15/2025
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.210
• Device Lot Number: 15273899
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 09/24/2021
• 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: Required Intervention
• Patient Sex: Unknown