MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Optical Decentration (1360)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2025
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 health care professional during intraocular lens (iol) implant procedure, reported that there was no trailing haptic and the surgeon left the iol in the patients lens bag and rotated the iol with only haptic inferiorly.Additional information received and stated that the intraocular lens is in the bag and decentration has occurred with uncorrected visual acuity 6/12, surgeon stated that the patient probably needs another operation to explant the lens and replace it.
Additional Manufacturer Narrative
Corrected information was provided a.1.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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: 22125006
• Report Number: 1119421-2025-01571
• Device Sequence Number: 8841544
• Product Code: HQL
• UDI-Device Identifier: 00380655093184
• UDI-Public: (01)00380655093184(17)291014(11)241016(10)15938019
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 15938019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/02/2025
• Date Device Manufactured: 10/16/2024
• 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: MONARCH III IOL , CARTRIDGE D; MONARCH III IOL INJECTOR; VISCOAT OVD
• Patient Age: 49 YR
• Patient Sex: Male