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

Model Number	SN60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) after implantation a mark was observed on the central optic zone of the iol.The lens was removed during initial procedure and backup lens was inserted without any complications.Additional information has been requested.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.3., d.4., h.3., h.4., h.6., and h.11.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information provided in h.6.Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo and video were returned.The reported complaint cannot be confirmed from the returned photo and video.Provided photo shows an iol carton with suspect lens.No lens is visible.Provided video shows a closed lens case with suspect lens and a lens on a piece of gauze.The reported complaint cannot be confirmed from the returned video due to the quality of the video.The reported complaint cannot be confirmed from the provided photo and video.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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: 23597745
• Report Number: 9612169-2025-02314
• Device Sequence Number: 9381817
• Product Code: HQL
• UDI-Device Identifier: 00380655093283
• UDI-Public: (01)00380655093283(17)280109(11)230111(10)25569468
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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.245
• Device Lot Number: 25569468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 01/16/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/30/2025; 02/11/2026
• Date Device Manufactured: 01/11/2023
• 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: TOPIRAMATE AND ESCITALOPRAM.; UNKNOWN CARTRIDGE.; UNKNOWN INJECTOR/HANDPIECE.
• Patient Age: 65 YR
• Patient Sex: Female