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

Model Number	SN60WF
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that following cataract surgery with intraocular lens (iol) implant procedure, immediately noticed changes on the surface.In almost a whole quadrant, there were irregularities/deposits on the anterior surface, which were colorless, mostly in the mid-peripheral area in a circular pattern, with numerous satellites around it.The lens was left in the eye even though the most central changes just barely touch the visual axis.The patient was very satisfied, vision was good, and the eye was completely calm.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.Photo review: upon reviewing the appearance of these photographs and referencing the information in the initial report description, along with the complaint lot search findings indicating no other complaints have been reported against the associated intraocular lens (iol) lot, the exact nature of the reported findings shown in these photographs cannot be determined.Further evaluation, requiring additional supporting information and/or materials, is needed to assess the relevance of these photographs to the complaint investigation.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 21025431
• Report Number: 9612169-2024-01438
• Device Sequence Number: 20915353
• Product Code: HQL
• UDI-Device Identifier: 00380655093245
• UDI-Public: (01)00380655093245(17)281102(11)231105(10)25742608
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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.225
• Device Lot Number: 25742608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 11/05/2023
• 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 INJECTOR.; MONARCH III CARTRIDGE D.; PROVISC.
• Patient Sex: Unknown