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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A physician reported that two years after intraocular lens (iol) implantation, the patient experienced lecog/possible phimosis in the eyes.The surgeon performed posterior and anterior yttrium-aluminum-garnet laser (yag) capsulotomies.There are two medical device reports associated with this patient.This report is associated with the left eye.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
The provided photo was reviewed.The same photo was attached to the bilateral file.The photograph was through the oculars of a slit lamp microscope of what appears to be a pciol visible through an undilated round pupil at moderate magnification.There appeared to be 360 degrees of anterior capsular opacification (phimosis) of moderate to dense opacification with the visual axis clear.The appearance of these opacities likely represents lens epithelial cell on-growth (lecog).Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The handpiece and viscoelastic used were not provided.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.The provided photo was reviewed.This likely demonstrates anterior capsular opacification (phimosis).The risk factors for this condition are many and include chronic ocular inflammation and diabetes.Additionally, it can be more common in certain lens materials as it is a phenomenon associated with capsular bag biocompatibility and has been reported in many iols with different types of biomaterials.It is usually self-limited.Information was provided that the patient has diabetes.The patient had intravitreal injections of in 2022 for amd.File will be reopened if new 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: 18408141
• Report Number: 1119421-2023-02231
• Device Sequence Number: 18133690
• Product Code: HQL
• UDI-Device Identifier: 00380655093306
• UDI-Public: 00380655093306
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.255
• Device Lot Number: 12681519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 02/22/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/02/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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: DUOVISC VISCOELASTIC SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown