MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during the intraocular lens (iol) implantation procedure, the doctor noticed a scratch on the lens surface under the microscope before loading it.The lens was set aside, and no replacement lens was implanted in the patient.The patient¿s other eye (left eye) was successfully operated but the right eye procedure could not be finished on that day as there was no backup lens available.Two days later, the procedure was completed when the new lens arrived.Additional information received stating that patient was left aphakic on (b)(6) 2025.
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
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.Both haptics were bent in the gusset and distal area against the posts of the lens case.The optic had a light scratch on the anterior side near the center.The optic was pressed between the posts and leaning down into the well area of the lens case.Product history records were reviewed, and documentation indicated the product met release criteria.Associated products were indicated; however, file was reported as damaged when opened.The product investigation could not identify a root cause for the reported complaint.The reported lens damage was observed.The observed damage is similar in appearance to handling related damage.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21593127
• Report Number: 1119421-2025-00665
• Device Sequence Number: 15684662
• Product Code: POE
• UDI-Device Identifier: 00380652421140
• UDI-Public: (01)00380652421140(17)251105(11)201106(10)15112284
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 11/05/2025
• Device Model Number: DFT015
• Device Lot Number: 15112284
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: DISCOVISC OVD.; MONARCH III IOL CARTRIDGE D.; MONARCH IOL INJECTOR, UNSPECIFIED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female