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

Model Number	CNW0T3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation procedure, a large scratch was confirmed on the optical part, after inserting the lens.The surgery was completed by retaining the lens in the patient's eye.Additional information was requested and received stating there was no patient impact/injury.
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).
Additional Manufacturer Narrative
The product was not returned for analysis.Only video was provided.Video review: the returned video shows iol implantation.The preparation of delivery system is not visible on the provided video.The nozzle is inserted into incision.When the iol is advancing, the plunger appears to underride the lens.The nozzle is removed from the incision when the lens is partially inserted into the eye.The lens is observed stuck in the incision and the iol implantation is completed with additional instrumentation.When the iol is fully implanted, the optic area is observed to be scratched/fractured, a large stutter scratch/fracture is observed at the optic edge area.Additional information: the complainant states the use of non company as viscoelastic, which is not qualified to be used with the associated iol model.Root cause: based on our observation of the video provided by the customer, the plunger appears to underride the lens during implantation.The lens is observed to be damaged (scratched/fractured) when implanted into the eye.Based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 16096750
• Report Number: 9612169-2023-00020
• Device Sequence Number: 6559115
• Product Code: MJP
• UDI-Device Identifier: 00380652409735
• UDI-Public: 00380652409735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 03/16/2025
• Device Model Number: CNW0T3
• Device Lot Number: 25298681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• 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: CLAREONMONARCH IV IOL INJECTOR; MONARCH III IOL, CARTRIDGE D; OVD: OPELEAD
• Patient Age: 77 YR
• Patient Sex: Male