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

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced with waxy vision and complained of visual discomfort.The lens was exchanged for another lens model 07 days following the initial procedure.The iol was replaced with a single focus one and the visual acuity improved, there was no health damage to the patient.Additional information was received from surgeon and stated that patient's condition was good after the replacement to the monofocal iol.There are two medical device reports associated with this report.This is 2 of 2.
Additional Manufacturer Narrative
Correction information was provided in d.4.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.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6 and h.11.The product was returned for analysis and the reported complaint could not be confirmed.Iol (intra ocular lens) returned in two segments wrapped in surgical material inside a zip lock bag.Solution is dried on the iol.Both haptics are intact.The optic is torn/split-cut and scratched/marked-rejectable.Company lens was replaced with monofocal lens.An impact to the visual acuity of the patient cannot be verified by examination of the returned product.Power and resolution testing could not be conducted due to the optic damage.Based on these investigation findings, we are unable to verify if the iol contributed to the event.The exchange to a monofocal lens, may suggest that the replacement lens model was an improved choice for the patient's vision needs.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 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: 20101172
• Report Number: 9612169-2024-00835
• Device Sequence Number: 7748388
• Product Code: MFK
• UDI-Device Identifier: 00380652407953
• UDI-Public: (01)00380652407953(17)260702(11)220704(10)25443118
• 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,Followup
• Report Date (Section B): 11/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.115
• Device Lot Number: 25443118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 08/30/2024; 10/21/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/27/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: MONOFOCAL - REPLACEMENT LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown