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

Model Number	DFT015
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137)
Date of Event	11/17/2024
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 non health care professional reported that after surgery, patient was unable to see the objects clearly and everything was appearing cloudy.Doctor has examined the eye and informed that the eye was perfect.The issue may be with the lens, because of which the patient was unable to get the vision.Additional information received and it states that the patient condition on discharge was stable.No eye pain and fit for discharge, the course in hospital was uneventful.Patient admitted, operated, discharged in same day without any complications.Additional information received and it states that the patient while performing surgery, same lens implanted in the sulcus.On the next day patient came for a post-operative follow-up with a clear cornea but a decentered intraocular lens (iol) noted.Repositioning of iol was performed on the same day.Also, on the other day patient presented with high intraocular pressure (iop) but was comfortable after receiving medications.During the follow-up, the patient's unaided vision was recorded as 6/6 p, and the best corrected vision was also 6/6 p.Doctor has advised the patient to proceed with second eye implant.However, the patient has not returned for the follow-up yet.According to doctor, the patient seems to be bit fussy, he asked several detailed questions for all the available iol's from different companies.He ultimately decided to proceed with company model.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21354293
• Report Number: 1119421-2025-00346
• Device Sequence Number: 21070402
• Product Code: POE
• UDI-Device Identifier: 00380652421287
• UDI-Public: (01)00380652421287(17)280625(11)230628(10)15670443
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: DFT015
• Device Lot Number: 15670443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 06/28/2023
• 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: CAP RETIHERB/I-HERB.; MOXISHIELD (E/D).; NEXANAC (E/D).; SYMHYLO (B/W).; TAB BIGUARD.; TAB MOXISHIELD.; TAB PAN 40.; TROOPED (B/D).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male