MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET5
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
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 health care professional reported that during an intraocular lens (iol) implant procedure, when filling the iol into the company cartridge with viscoelastic it behaved abnormally.When advancing the plunger, the iol got stuck in the tip area.Further manipulations to safely remove the iol from the cartridge for refilling into the cartridge and implantation were unsuccessful.As a result, the iol was completely damaged.The patient was not injured.An iol of the same model and diopter was implanted.Additional information was received, there was no patient contact and no harm to the patient.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.Only photo was returned.The reported lens damage can be observed on the returned photo.Photo provided shows an iol (intra ocular lens) against unknown background.One haptic is missing, the other haptic appears to be damaged.The iol optic appears to be cracked.Based on our observation of the attached photo, one haptic is missing, the other haptic appears to be damaged.The iol optic appears to be cracked.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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 Key: 20644555
• Report Number: 9612169-2024-01145
• Device Sequence Number: 18019071
• Product Code: MJP
• UDI-Device Identifier: 00380652467094
• UDI-Public: (01)00380652467094(17)270218(11)230220(10)25602190
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET5
• Device Catalogue Number: CNWET5.170
• Device Lot Number: 25602190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 02/20/2023
• 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; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown