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

Model Number	CNW0T4
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional 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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, after implanting the lens into the capsule bag the surgeon noticed that the front and back surfaces of the lens were cloudy.She tried to wash the surface of the lens by irrigation but it did not give any result.The lens was still in the patient eye and there were no complications noted.Additional information was received and stated that a second intervention is not yet required and visual acuity on the first day after surgery was 0.2.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.The product was not returned for analysis.Only photo was returned.Video review performed: a video was provided imaging the eye through an aperture where it was reported that, after implanting the lens into the capsule bag, the surgeon saw that the front and back surfaces of the lens were cloudy¿ which could not be removed by irrigation.A diffuse cloudy appearance is present across the lens where the cause is unable to be determined from the video and further identification would require clinical review beyond this image assessment.Based on review of the attached photo, the iol (intra ocular lens) appears cloudy.A definitive determination of iol condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 19308441
• Report Number: 9612169-2024-00437
• Device Sequence Number: 15287026
• Product Code: MJP
• UDI-Device Identifier: 00380652410137
• UDI-Public: (01)00380652410137(17)270704(11)230706(10)25677000(21)25677000067
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 25677000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; VISCOELASTIC - KOGEVIST.
• Patient Age: 70 YR
• Patient Sex: Male