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

Model Number	SN60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that after an intraocular lens (iol) implantation procedure, noticed iol¿s appear on the slit lamp to be opacifying causing visual acuity loss.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The file states the iols appear on the slit lamp to be opacifying causing visual acuity loss.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.At this point, no further information available at this time.The file will be reopened if additional information is provided.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: 18463561
• Report Number: 1119421-2024-00042
• Device Sequence Number: 15240165
• Product Code: HQL
• UDI-Device Identifier: 00380655095669
• UDI-Public: 00380655095669
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 04/30/2012
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.125
• Device Lot Number: 10725537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2007
• 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