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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS Back to Search Results
Model Number CC60WF
Device Problem Scratched Material (3020)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  Injury  
Event Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, there was a scratch in middle of the lens.The lens was exchanged for another lens model 1 month following the initial procedure.Additional information has been received and stated that there was no patient harm and patient issues was resolved.
 
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).
 
Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.The product investigation could not identify a root cause for the reported complaint.The account indicated the product was not available to evaluate.The account indicated the use of qualified associated products.The instructions for use (ifu) instructs: the ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.File will be reopened when new information is received.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CLAREON ASPHERIC UV ABSORBING IOL
Type of Device
INTRAOCULAR LENS
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 Key19116776
MDR Text Key340285827
Report Number1119421-2024-00727
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380652396769
UDI-Public00380652396769
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/16/2024
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? Yes
Device Operator Health Professional
Device Model NumberCC60WF
Device Lot Number15615025
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MCPHERSON NON-TOOTHED FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient SexFemale
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