MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	CC60WF
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that during surgery, they were unable to get implant to unfold in the eye.Trailing haptic was stuck to center of implant upon insertion.Surgeon was able to grasp the end of the implant and pull it out of the primary wound without cutting the iol into pieces.New iol used instead.No patient harm.Additional information has been requested.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.A photo was provided of the lens case being held by an ungloved hand.The lens appears to be adhered to the label on the outside of the lens case.One haptic is bent at the gusset area.Viscoelastic is present on the lens.Product history records were reviewed and the documentation indicated the product met release criteria.Based on our observation of the attached photo, the haptic is bent and clinical solution appears to be present on the lens.The root cause is most likely related to a failure to follow the ifu.Information was provided that the account indicated the lens was in the device for 4 to 5 minutes before delivery.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.It is difficult to make a determination of handling / damage without evaluation of the physical sample.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 19973833
• Report Number: 1119421-2024-01563
• Device Sequence Number: 7057384
• Product Code: HQL
• UDI-Device Identifier: 00380652396813
• UDI-Public: (01)00380652396813(17)280120(11)240122(10)15785420
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: CC60WF
• Device Lot Number: 15785420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 01/22/2024
• 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: MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D; MONARCH INJECTOR; PROVISC
• Patient Age: 64 YR
• Patient Sex: Female