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

Model Number	CNWTT0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation, a partial tear at the base of the haptic was noticed.But the surgery was performed and completed without product replacement.There were no postoperative problems, but later due to slight change in myopia and reduced visual acuity, the iol was replaced with a company lens in a secondary procedure.The physician said that patient felt some discomfort at the time of implantation during first operation, and also felt discomfort when the replacement lens was implanted later.Therefore, the replacement lens was also removed immediately and new lens was implanted.Additional information received stated that patient's symptoms have been recovering.
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 "partial tear of haptic" was observed.Intraocular lens (iol) returned in zip lock bag.Solution is dried on both surfaces of the remaining optic and one haptic.One haptic is broken/torn and not returned, the other haptic is intact.The optic is torn/split-cut dividing the iol in two, with a piece missing and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "partial tear of haptic, slight change in myopia and reduced visual acuity".Solution is dried on the returned iol.The optic is torn/split-cut dividing the iol in two, with a piece missing and scratched/marked-rejectable.The observed damage is consistent with lens having been explanted.The product was subject to handling and the reported "partial tear of haptic" was highlighted post implantation.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed "broken haptic" would not meet our current release criteria.The root cause for the reported "slight change in myopia and reduced visual acuity" could not be determined.The lens was replaced from company 6.5d to company 7.0d.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: 17974448
• Report Number: 9612169-2023-00734
• Device Sequence Number: 11669594
• Product Code: MFK
• UDI-Device Identifier: 00380652407854
• UDI-Public: 00380652407854
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2024
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.065
• Device Lot Number: 25229772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; SHELLGAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male