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

Model Number	SN60WF
Medical Device Problem Codes	Inaccurate Delivery (2339); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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 reported that during an intraocular lens (iol) implant procedure, when the lens was loaded and the surgeon was holding it, the lens prematurely came out of the cartridge before delivery into the eye.The lens was reloaded, and while inserting into the eye, the lens got stuck in the wound, so it was reloaded again.Then the lens got stuck in the cartridge.The surgeon requested a new lens, new cartridge, and new injector.New items were given, then checking and loading were done, and the procedure was completed on the same day.Everything went well.Additional information has been requested, received and stated there was no patient harm.
Additional Manufacturer Narrative
Correction information was provided in h.11.Based on further reassessment, when the lens was loaded and the surgeon was holding it, the lens prematurely came out of the cartridge before delivery into the eye.The lens was reloaded, and while inserting it into the eye, the lens got stuck in the wound, so it was reloaded again.Then, the lens got stuck in the cartridge, which was solely the cause of user error, without patient harm.Based on this information, this event no longer met reporting criteria per applicable regulation, because the malfunction did not result in the failure of the device to perform its essential function or compromise its therapeutic, monitoring, or diagnostic effectiveness, which could cause or contribute to a death or serious injury or other significant adverse device experiences required by regulation; and although recurrence was presumed, it would not be expected to cause or contribute to a death or serious injury.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: 23447308
• Report Number: 1119421-2025-02829
• Device Sequence Number: 12990913
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: (01)00380655093160(17)291027(11)241029(10)15941402
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 01/06/2026

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.185
• Device Lot Number: 15941402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/07/2026
• Date Device Manufactured: 10/29/2024
• 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: DK7797-2 IOL INJECTOR; REPLACEMENT NEW CARTRIDGE; REPLACEMENT NEW INJECTOR; UNKNOWN CARTRIDGE; UNKNOWN VISCOELASTIC
• Patient Sex: Unknown