MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/28/2024
Type of Reportable Event	Serious 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).
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, when lens was implanted and being rotated into position, the peripheral capsule was noted to tear open along the optic edge anteriorly.The lens was removed and replacement sulcus lens was implanted.There was no patient impact and symptoms has been resolved.The surgeon said there was no difficulty noted with loading the iol or insertion of the iol and it may occurred at any point of time.
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was provided in h.3.,h.6 and h.11.The lens was returned for evaluation.Solution is dried on the lens.The lens is cut into multiple pieces, typical of insertion and removal from the eye.One piece has a notch missing from the edge of the optic.All three pieces were split and cracked.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.Lens damage was observed.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.The root cause is most likely a failure to follow the ifu (instructions for use).The file states the lens remained in the cartridge 5-6 minutes.Company lens ifu: follow the section regarding directions for use for information on the maximum allowed time for the iol (intraocular lens) 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20805765
• Report Number: 1119421-2024-02335
• Device Sequence Number: 9831313
• Product Code: MJP
• UDI-Device Identifier: 00380652409704
• UDI-Public: (01)00380652409704(17)270501(11)230503(10)15639757(21)15639757022
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNW0T3
• Device Lot Number: 15639757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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: ACRYSOF MULTIPIECE IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL INJECTOR; MONARCH III IOL CARTRIDGE D; PROVISC OVD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female