MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned for the evaluation.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 health care professional reported that 8 years following an intraocular lens (iol) implant procedure, the patient had a visit to surgeon clinic because of visual acuity decrease, where surgeon observed that that iol was opacified.The explantation of the lens was scheduled.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., d.6.B., h.6.And h.11.Information was provided that the lens was implanted (b)(6) 2016.The patient was diabetic.The vision issue was reported (b)(6) 2024.New information was provided that the lens was exchanged.The company, 19.5 diopter lens was exchanged for different model, 20.0 diopter company lens on (b)(6) 2024.Files will be reopened if further information is provided or if the sample is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, receive and stated that the lens was explanted and a same company different model 0.5 diopter more lens was implanted.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• 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: 20784735
• Report Number: 1119421-2024-02305
• Device Sequence Number: 9053128
• Product Code: HQL
• UDI-Device Identifier: 00380652358262
• UDI-Public: (01)00380652358262(17)190228(11)160324(10)12444316
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 02/20/2025

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 Expiration Date: 02/28/2019
• Device Model Number: AU00T0
• Device Lot Number: 12444316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/26/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 03/24/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male