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

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, upon opening the lens, it was found that one of the haptics was broken removed it from the injector, returned it to its packaging.There was patient contact but no patient harm, the surgery was finished with another iol.Additional information has been requested.
Additional Manufacturer Narrative
A product was not returned for analysis.The investigation conducted a nonconformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Provided photo shows an iol in a lens case base.The lens appears to be positioned incorrectly in the lens case base well, it appears to be sitting on a few of the lens case base posts.One haptic appears to be broken.Root cause has not been identified.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: 24630134
• Report Number: 9612169-2026-00627
• Device Sequence Number: 8596926
• Product Code: HQL
• UDI-Device Identifier: 00380655093207
• UDI-Public: (01)00380655093207(17)290427(11)240429(10)25849365
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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.205
• Device Lot Number: 25849365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 04/29/2024
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D.; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 77 YR
• Patient Sex: Male