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

Model Number	SN6AD1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, it was noticed that lens was moving around and causing blurry vision.It was mentioned that consumer was going to get the implant removed.Additional information has been received and stated vision was blurred, went to see retina specialist.Lens was dislocated.Scheduled for surgery next with retina specialist.Consumer will have monofocal lens replacement.No history of head injury or eye injury.Unknown cause for dislocation.Has been told he has a very large eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in d.4.And h.6.(fda evaluation method code b22 should be b14).Additional information provided in 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 lens remains implanted.No reason for the dislocation was provided.The reporter was the patient.The reporter indicated the lens was implanted 9 years ago.The reporter stated their vision was blurred.Retina specialist indicated the lens was dislocated.Future surgery to be scheduled.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 22150911
• Report Number: 1119421-2025-01594
• Device Sequence Number: 7634096
• Product Code: MFK
• UDI-Device Identifier: 00380652249522
• UDI-Public: (01)00380652249522(17)170331(11)120416(10)12141166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 03/31/2017
• Device Model Number: SN6AD1
• Device Lot Number: 12141166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 04/16/2012
• 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
• Patient Sex: Unknown