MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Glaucoma (1875); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient had glistening's (fluid droplets behind the lenses).The ophthalmologist advised the patient that the glistening's are likely the result of the manufacturing process of the lenses.The patient has issues with their night vision, specifically glaring and blurry vision, as a result and patient experienced difficulty seeing in low light.Additional information has been requested.There are two medical reports associated with same event.This file belongs to left eye.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Additional information has been received that the patient had a diagnosis of glaucoma, very mild pco (posterior capsular opacification) for which laser will not help the vision and glistening was discussed with the patient.The patient also had negative dysphotopsia in both eyes (ou), so no treatment is required for it.
Additional Manufacturer Narrative
Additional information has been provided in a,1.,a.2.,b.5.,b.6.,b.7.,h.3., h.6., and h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.No sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20890668
• Report Number: 9612169-2024-01278
• Device Sequence Number: 8773544
• Product Code: HQL
• UDI-Device Identifier: 00380655093207
• UDI-Public: (01)00380655093207(17)160831(11)110927(10)21042706
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 08/31/2016
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 21042706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2011
• 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 Age: 56 YR
• Patient Sex: Female