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

Model Number	CNW0T6
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported with a description of intraocular lens (iol) fails to pass through the tip of the cartridge, non-implanted.There was no patient harm.
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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was added in d.9., h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be observed.No cartridge was returned.Intraocular lens (iol) returned crushed in the lens case well area.Solution is dried on the iol.Both haptics are broken/torn.The optic is cracked/fractured and scratched/marked-rejectable.No cartridge returned.Due to the condition of the returned iol, it was unable to be measured dimensionally for edge thickness and plan view.The product investigation could not identify the root cause for the reported complaint "iol fails to pass through the tip of the cartridge" as only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The iol was damaged, a functional test to check the dimensions of the iol could not be conducted due to the condition of the returned sample.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: 20311659
• Report Number: 9612169-2024-00961
• Device Sequence Number: 12982636
• Product Code: MJP
• UDI-Device Identifier: 00380652410885
• UDI-Public: (01)00380652410885(17)260524(11)220526(10)25416432(21)25416432058
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2024

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 Expiration Date: 05/24/2026
• Device Model Number: CNW0T6
• Device Lot Number: 25416432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 11/12/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/22/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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: CENTURION VISION SYSTEM, ACTIVE SENTRY HANDPIECE; DUOVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Patient Age: 59 YR
• Patient Sex: Female