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

Model Number	SN60WF
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
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.Provided video show an iol implantation.The lens is in the eye.The haptics appear to be folded over the optic.The surgeon is trying to remove the haptics from the optic using a surgical tool.The complainant indicates the use of non company ovd as a viscoelastic which is not qualified for use with the associated iol model.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, after implantation of lens it was noted that both the lens haptics were tightly adhered to the optic and could only be separated with difficult manual manipulation.There was a patient contact reported.The patient undergone for unspecified intervention.As per the physician there was a unspecified impact to the patient and the impact was continued with the patient.Additional information has been requested, received and stated patient current condition was good.This report is associated with multiple complaints.This file is 1 of 5.

• 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: 24605825
• Report Number: 9612169-2026-00590
• Device Sequence Number: 13348114
• Product Code: HQL
• UDI-Device Identifier: 00380655095751
• UDI-Public: (01)00380655095751(17)260509(11)210511(10)25161619
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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 Expiration Date: 05/09/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.275
• Device Lot Number: 25161619
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 05/11/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; NON COMPANY OVD (BIOTECH BIO-HYALUR ); NON COMPANY SURGICAL PACK
• Patient Sex: Unknown