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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS
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ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number CCWTT3
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Blurred Vision (2137); Halo (2227)
Date of Event 08/27/2024
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A product 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).
 
Event or Problem Description
A facility representative reported, that following an intraocular lens (iol) implant procedure.The patient, experienced blurred vision, hazy and halos.The iol was exchanged for another lens 7 months following the initial procedure.Clinical reason for explant was mentioned as mechanical defect.Additional information provided, that there was no patient impact.
 
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens was cleaned with klrp for further evaluation.One haptic has a scratch on the distal tip on the anterior surface.Scratches and cracks are observed near the edge of the optic near a gusset area.A power and resolution inspection was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.Each lens is subjected to a 100 percentage assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the toric company model (1.50 cylinder), 19.0 diopter lens was replaced with a non-company monofocal 19.0 diopter lens.Due to the exchange of a toric multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patients vision needs.The manufacturer internal reference number is: (b)(4).
 
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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 Key20805832
Report Number1119421-2024-02337
Device Sequence Number9302362
Product Code MJP
UDI-Device Identifier00380652457361
UDI-Public(01)00380652457361(17)260724(11)220726(10)15461126(21)15461126054
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P190018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Reporter Type Manufacturer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 12/27/2024
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 Date07/24/2026
Device Model NumberCCWTT3
Device Catalogue NumberCCWTT3.190
Device Lot Number15461126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2024
Type of Report(Section G)Follow-Up
Initial Date Received by Manufacturer 10/31/2024
Supplement Date Received by Manufacturer11/29/2024
Initial Report FDA Received Date11/28/2024
Supplement Report FDA Received Date12/27/2024
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured07/26/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ARGOS BIOMETER.; MONARCH II LOADING FORCEPS.; MONARCH III IOL CARTRIDGE D.; MONARCH III IOL INJECTOR.; PROVISC OVD.
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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