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

Model Number	CNW0T6
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported with a description of during intraocular lens (iol) implant procedure, the haptic was torn when the lens was implanted, causing a crack in the optical part.It has been confirmed that the injector, cartridge, and ovd were used properly.The surgery has now been completed and the torn lens has been implanted as it was.The surgeon plans to consider whether to replace the patient based on the postoperative course.The torn haptic and cartridge were returned.Additional information has been received stating the surgeon considers that it was unlikely that the cartridge was a factor.
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 returned for analysis and the reported condition was observed.Intraocular lens (iol): one haptic returned in a bag.Solution is dried on the haptic.Cartridge: the associated qualified company cartridge was returned.Inadequate viscoelastic was observed in the cartridge.The tip has heavy stress beginning after the fill line and the posterior of the cartridge tip has cracked.The cartridge wings shows evidence of being placed into a handpiece.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.All listed associated products were qualified for use with the cartridge.Based on the evaluation of the returned cartridge and the evaluation of the damaged returned lens, the root cause was most likely related to a failure to follow the instruction for use (ifu).An inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19181150
• Report Number: 9612169-2024-00366
• Device Sequence Number: 15306807
• Product Code: MJP
• UDI-Device Identifier: 00380652411196
• UDI-Public: 00380652411196
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: CNW0T6
• Device Lot Number: 25555741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown