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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
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ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS Back to Search Results
Model Number CCWET0
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Blurred Vision (2137)
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 blurry vision.The lens was exchanged for non-company lens model 2 months following the initial procedure.Additional information received that the patient symptoms were improving.There was no patient impact.
 
Additional Manufacturer Narrative
Corrected information provided in d.4.Additional information provided in e.4.And h.3.The manufacturer internal reference number is: (b)(4).
 
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Iol returned in two segments inside a sample container.Solution is dried on the iol.One haptic is adhered to the optic surface with solution, the other haptic is intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
Common Device Name
EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI  00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI   00000
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key20516765
Report Number9612169-2024-01061
Device Sequence Number7718239
Product Code POE
UDI-Device Identifier00380652405720
UDI-Public(01)00380652405720(17)251116(11)211118(10)25307286(21)25307286021
Combination Product (Y/N)N
Initial Reporter StateMO
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,Followup
Report Date (Section B) 01/06/2025
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 Date11/16/2025
Device Model NumberCCWET0
Device Catalogue NumberCCWET0.175
Device Lot Number25307286
Was Device Available for Evaluation? Device Returned to Manufacturer
Type of Report(Section G)Follow-Up
Initial Date Received by Manufacturer 09/24/2024
Supplement Date Received by Manufacturer10/24/2024
12/12/2024
Initial Report FDA Received Date10/23/2024
Supplement Report FDA Received Date11/21/2024
01/06/2025
Date Device Manufactured11/18/2021
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
AMVISC PLUS.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; REPLACED WITH MX6E017.5.
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
Patient SexFemale
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