MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that, upon opening the iol it was discovered that the lens was improperly positioned in the container, resulted in the haptic part being bent at an incorrect angle and crumpled.The lens was implanted and the surgery was completed despite the defect, and the surgeon believed that the lens remains a high risk of iol decentration during the postoperative period.It was also stated that reimplantation may be required.The patient was under observation.Additional information received and stated that the patient condition was satisfactory with the results of distance vision of 100 percent and near vision 50 percent and no reimplantation was required.
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 was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only video and photo were returned.The reported complaint can be observed on the returned video and photo.Video review.Video provided shows an iol inside a lens case base.Solution is observed on the iol.One haptic appears to be positioned incorrectly and bent back against one of the lens case posts.Surgeon removes lens with tweezers.There also appears to be damage to the optic edge as a result of the iol being pressed against the lens case posts.Photo review.Returned photo pic2 shows an iol in a lens case base on a screen.One haptic appears to be bent and incorrectly positioned in the case.The root cause is deemed to be manufacturing related.Based on our observation of the attached video and photo, one haptic appears to be positioned incorrectly and bent back against one of the lens case posts.There also appears to be damage to the optic edge as a result of the iol being pressed against the lens case posts.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 VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 21393043
• Report Number: 9612169-2025-00225
• Device Sequence Number: 8705345
• Product Code: POE
• UDI-Device Identifier: 00380652405218
• UDI-Public: (01)00380652405218(17)270219(11)230221(10)25602213
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: CNWET0
• Device Catalogue Number: CNWET0.185
• Device Lot Number: 25602213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 02/21/2023
• 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: CLAREON MONARCH IV IOL, INJECTOR.; MONARCH III IOL, CARTRIDGE D.
• Patient Age: 75 YR
• Patient Sex: Female