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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during surgery, they noticed that identified iol haptic amputation after implantation.The lens was cut and explanted, and replaced with another available lens.Procedure was completed on the same day.No patient harm.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 has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photos show an iol in a lens case base.The lens is not positioned correctly in the well of the lens case base, it appears to be posterior surface up instead of anterior surface up in the iol case.One haptic appears to be broken and sitting on top of the optic.The other haptic appears to be deformed with broken tip.The complainant indicates the use of non company viscoelastic which is not qualified for use with the associated iol model.Based on our observation of the attached photo, " the lens is not positioned correctly in the well of the lens case base, it appears to be posterior surface up instead of anterior surface up in the iol case.One haptic appears to be broken and sitting on top of the optic.The other haptic appears to be deformed with broken tip".According to the information provided by the customer, the most likely root cause is failure to follow ifu, as the customer states the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the implantation process.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: 22873969
• Report Number: 9612169-2025-01694
• Device Sequence Number: 21425479
• Product Code: HQL
• UDI-Device Identifier: 00380655095713
• UDI-Public: (01)00380655095713(17)280314(11)230317(10)25612530
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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.150
• Device Lot Number: 25612530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 03/17/2023
• 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: METILCELULOSE 2%OPHTALMOS 2% LOT: 082423C.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.
• Patient Age: 66 YR
• Patient Sex: Male