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	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
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 healthcare professional reported that lens had a crack.Lens has been placed in eye.It is unknown if crack was already there or if this happened during the placement.They we suspect that it was already there because the placement went smoothly.Additional information received stating that lens tear was not obstructing vision.The current status of the patient was satisfied and no complaints.The patient was on injections for macular degeneration, so it was not expected that vision would become 1.0.Break line of the lens outside the optical axis.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The sample was not returned.A photo was provided.A lens was shown already implanted into the eye.Circular glare from the overhead lights are visible on the optic.An area of concern was circled in red.This area was on the optic edge.The area appeared as a blurry, shadowy line.The shadowy line was most likely optic damage.A physical sample would be necessary in order to make a confirmation.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.Based on our observation of the attached photo, the optic has a shadowy line at the edge.Due to the poor clarity of the photo, it is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 21240959
• Report Number: 1119421-2025-00232
• Device Sequence Number: 12894959
• Product Code: HQL
• UDI-Device Identifier: 00380652394765
• UDI-Public: (01)00380652394765(17)261008(11)231010(10)15711399
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/01/2025

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: AU00T0
• Device Lot Number: 15711399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/01/2025
• Date Device Manufactured: 10/10/2023
• 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: PROVISC OVD
• Patient Age: 76 YR
• Patient Sex: Male