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	02/04/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, after phacoemulsification, prior intraocular lens (iol) implantation, company lens opened and dropped ophthalmic viscosurgical device (ovd) on the optic, used company cartridge and company injector but found lens one side haptic torn in the cartridge and product defect observed.Doctor not to proceed with the implantation of defect lens, change to another unspecified new intraocular lens and another unit of company injector to proceed and complete the lens implantation.No patient contact was reported.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d9, h3, h6, and h11.Intraocular lens (iol) returned positioned incorrectly in the iol case.Solution is dried on the iol optic and the haptic.One haptic is broken/torn and not returned, the other haptic is bent/deformed.The optic is torn/split-cut dividing the iol in two segments which are still partially attached to each other.The optic is scratched/marked-rejectable.The company cartridge was returned.Inadequate viscoelastic was observed in the cartridge.No damage was observed.The cartridge had evidence of placement into a handpiece.The company cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.The root cause for the reported complaint appears to be related the a failure to follow the ifu (instructions for use).Inadequate viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Based on the results from the product history record, the products met release criteria.The manufacturer's 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: 21527783
• Report Number: 9612169-2025-00328
• Device Sequence Number: 8339566
• Product Code: HQL
• UDI-Device Identifier: 00380655095645
• UDI-Public: (01)00380655095645(17)260601(11)210603(10)25140358
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/21/2025

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: 06/01/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.115
• Device Lot Number: 25140358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown