MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that after a cataract surgery, they noticed that the surgeon had a patient with an iol implanted in 2020 that now had turned white.Additional information has been requested and received stating that, on (b)(6) 2020, cataract operation performed on left eye which was uncomplicated.On (b)(6) 2020, lens residue removed from anterior chamber.On (b)(6) 2020, cataract operation performed on left eye which was uncomplicated.On (b)(6) 2023, yag membraneectomy was performed on left eye.Slightly cloudy iol was noted here on both sides.On (b)(6) 2025, yag membraneectomy was performed on left eye.Secondary cataract surgery with capsular bag distension syndrome.Quite pronounced cloudy iol in both eyes, primarily left eye was noted.The patient had been offered removal of a fairly cloudy iol for the left eye, but had not yet requested it.There are two bilateral reports associated with this patient.This file belongs to left eye.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the patient has been offered removal of a iol, but has not requested at this time.No visual issues have been reported.File will be reopened if new information or the sample us received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• 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: 21925121
• Report Number: 1119421-2025-01204
• Device Sequence Number: 8728892
• Product Code: HQL
• UDI-Device Identifier: 00380652395151
• UDI-Public: (01)00380652395151(17)221130(11)191203(10)12762944
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 06/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: ACU0T0
• Device Lot Number: 12762944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 12/03/2019
• 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: 73 YR
• Patient Sex: Female