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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 during intraocular lens implant procedure the surgeon noticed the lens opacity (turn cloudy), the lens was removed during initial procedure and replaced with company lens.Additional information has been received and stated that there was no patient harm.
Additional Manufacturer Narrative
On initial mdr the product problem code of a0409 was an error.It should have been a0407 on the original mdr.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3.And h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The root cause for the reported visual anomaly may be related to user handling.Information was provided that the lens was inside a warmer before surgery.The lens does not require warming.This is not part of the ifu.It is unknown what temperature range the lens was exposed to or if moisture was present.If the warmed lens was loaded with cold (or temp) viscoelastic the extreme change in temperature may have caused the reported visual anomaly.This anomaly would have disappeared once the lens temperate equilibrated.The file will reopened if the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned pressed into the well area of the 78(iw) lens case.Viscoelastic was observed on the lens.The lens had been cut into two pieces across the center of the optic (typical of a removal).The pieces were returned adhered to each other.The lens did not appear cloudy.The lens was cleaned with klrp to remove the dried viscoelastic and separate the pieces.The lens had no areas that appeared cloudy after removal of the viscoelastic.Scratches were observed which may have occurred during the removal.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The lens was returned in two pieces.The lens was not cloudy before or after cleaning.Damage was observed which may be related to the removal process.The root cause for the reported visual anomaly may be related to user handling.Information was provided that the lens was inside a warmer before surgery.The lens does not require warming.This is not part of the ifu.It is unknown what temperature range the lens was exposed to or if moisture was present.If the warmed lens was loaded with cold (or temp) viscoelastic the extreme change in temperature may have caused the reported visual anomaly.This anomaly would have disappeared once the lens temperate equilibrated.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20513181
• Report Number: 1119421-2024-02052
• Device Sequence Number: 12915716
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: (01)00380655093177(17)281001(11)231004(10)15724958(21)15724958004
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2025

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.190
• Device Lot Number: 15724958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 12/04/2024; 01/16/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/31/2024; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR
• Patient Age: 68 YR
• Patient Sex: Female