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

Model Number	CNW0T5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
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 physician reported that a crack was found at the iol optics.The surgery was performed and completed after replacing the product with another one.The involved eye and the patient identifier were not available.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol returned in lens case in two segments, adhered to each other with solution.Solution is dried on the iol.One haptic is adhered to the optic surface with solution, the other haptic is bent/deformed.The optic is cracked/fractured and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint.The returned iol has solution dried on the iol.The product was subject to handling as the reporter has advised the iol was explanted.All iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.The product history records confirm that the product 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: 18834873
• Report Number: 9612169-2024-00185
• Device Sequence Number: 7132849
• Product Code: MJP
• UDI-Device Identifier: 00380652410687
• UDI-Public: 00380652410687
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/29/2024

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: 08/13/2026
• Device Model Number: CNW0T5
• Device Lot Number: 25469601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III CARTRIDGE D; PROVISC
• Patient Sex: Unknown