MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, it was noted that the lens trailing haptic had torn during implantation.Despite this situation, it was possible to implant it in the capsule, so it was implanted as it was and put under observation.However, during a check-up four days later, displacement of the lens was confirmed.The next day, the lens was explanted in a re-operation, and a new company lens of the same model was implanted.Additional information has been requested, received and stated patient visual acuity was good after the replacement surgery.
Additional Manufacturer Narrative
Additional information was added in d.9., h.3., h.6 and h.11.The product was returned for analysis and damage was observed to the intra ocular lens(iol).Iol returned in sample container.Solution is dried on the iol.One haptic is broken/torn and not returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "trailing haptic got torn, displacement of lens".The product was subject to handling and the reported damage was highlighted post implantation.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.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 TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20620397
• Report Number: 9612169-2024-01124
• Device Sequence Number: 7534749
• Product Code: MFK
• UDI-Device Identifier: 00380652408028
• UDI-Public: (01)00380652408028(17)260530(11)220601(10)25424253
• 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
• Device Explanted 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): 12/31/2024

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 Expiration Date: 05/30/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.150
• Device Lot Number: 25424253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 PANOPTIX TRIFOCAL HYDROPHOBIC IOL; MONARCH III IOL CARTRIDGE D; VISCOAT OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown