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

Model Number	CCWET3
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Corneal Edema (1791); Eye Injury (1845); Vitreous Floaters (1866); Visual Impairment (2138)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer who is a healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed that the lens was cracked following placement.Lens was broken into pieces during process to remove defective lens.Patient was waiting for appointment to determine that all defective lens pieces were removed from eye.Additional information has been received stating symptoms in the right eye were reported as reduced visual acuity, excess fluid in the right eye and excess floaters.An ultrasound of the right eye was scheduled to determine if all the pieces of the broken lens have been removed from the right eye.Current prescription was nacl 5 percentage eye drops in right eye four times a day.Additional information has been received stating iol material would break off, surgeon had to enlarge incision to remove material not as tough as other model of company lens.Procedure was completed on the same day.Surgeon's opinion, possibly lens material more brittle or possibly company injector was related.Harm was unknown at the time of reporting, and corneal edema was resolving.Patient issues were not resolved.Surgeon's prognosis was reported as likely good.
Additional Manufacturer Narrative
G.9.This report originally filed as manufacturing report number 9612169-2024-00580.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Correction information was provided in d.4.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION 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: 19983200
• Report Number: 1119421-2024-01575
• Device Sequence Number: 8234691
• Product Code: MJP
• UDI-Device Identifier: 00380652455350
• UDI-Public: (01)00380652455350(17)270710(11)230712(10)15655797(21)15655797089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.235
• Device Lot Number: 15655797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 07/12/2023
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; LOADING/ FOLDING FORCEPS CURVED TYRE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female