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

Model Number	SN60WF
Medical Device Problem Codes	Material Discolored (1170); Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that, after intraocular lens implantation surgery, the patient reported opacified lens.Additional information was requested.
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 h.6 (fda product code a0407 code has updated to a0409) additional information was provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in h.11 (b14 code has been added).Additional information was provided in h.3., h.6., and h.11.The product was not returned.A photo evaluation was provided by patient safety & experience: five slit lamp photographs of similar appearance were provided for review.The lens images appear to show a general diffuse haziness which could potentially be associated with a confluence of microvacuoles sometimes referred to as subsurface nano glistenings.The location of the reported appearance is not able to be determined based on the images provided and a more conclusive determination would require clinical assessment beyond this review.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Five slit lamp photographs of similar appearance were provided for review.The lens images appear to show a general diffuse haziness which could potentially be associated with a confluence of microvacuoles sometimes referred to as subsurface nano glistenings.The location of the reported appearance is not able to be determined based on the images provided and a more conclusive determination would require clinical assessment beyond this review.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: 22629419
• Report Number: 1119421-2025-02072
• Device Sequence Number: 20830579
• Product Code: HQL
• UDI-Device Identifier: 00380655093290
• UDI-Public: (01)00380655093290(17)140531(11)090630(10)10930083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 04/01/2026

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 Expiration Date: 05/31/2014
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.250
• Device Lot Number: 10930083
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 03/10/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 03/05/2026; 04/01/2026
• Date Device Manufactured: 06/30/2009
• 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