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

Model Number	CCWTT4
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
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 facility representative reported that during surgery, they noticed that lens was scratched.There was patient contact.Procedure was not completed on the same day.Additional information has been requested and received stating that the lens was scraped during implantation/or manipulation by the doctor.No patient harm reported.
Additional Manufacturer Narrative
Additional information has been provided in d.4., h.3., h.6., and h.11.The product was not returned for analysis.The reporter stated "lens scraped during implantation and/or manipulation by dr." the root cause for the reported complaint could not be determined as no sample was returned for analysis.The reporter stated via the retuned questionnaire: "lens scraped during implantation and/or manipulation by dr." although no clarification was received as to whether the product caused or contributed to the event? 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 PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 19533991
• Report Number: 9612169-2024-00559
• Device Sequence Number: 7704331
• Product Code: MJP
• UDI-Device Identifier: 00380652457781
• UDI-Public: (01)00380652457781(17)260705(11)220707(10)25443099(21)25443099066
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 07/05/2026
• Device Model Number: CCWTT4
• Device Catalogue Number: CCWTT4.135
• Device Lot Number: 25443099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• Date Device Manufactured: 07/07/2022
• 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 IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 68 YR
• Patient Sex: Female