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

Model Number	SN60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical engineer reported that during an intraocular lens (iol) implant procedure, according to the technovigilance report, an incident was identified related to the intraocular lens, indicating possible quality defects.Additional information was received by stating, during lens rotation, a complete lens amputation was observed within the capsular bag.There was no patient impact.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 has been provided in d.3., d.4., d.9., h.3., h.6., and h.11.The product was returned for analysis.Lens received outside of the lens case, attached to a piece of fabric.Solution is dried on the lens.The optic is torn/split-cut dividing the iol (intraocular lens) in two.One haptic is broken/torn and not returned.The two lens halves are connected by the present haptic, which is adhered to the optic with solution.There are fractures in the optic segment with the retained haptic.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.We are unable to determine the root cause for the reported complaint "during lens rotation, a complete lens amputation observed in the capsular bag, no pt".The iol was returned in two pieces, which is consistent with lens having been explanted.The product was subject to handling, and the reported damage was highlighted post implantation.The reported complaint is lacking in relevant information such as associated products (cartridge, handpiece, viscoelastic) used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.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 WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24322090
• Report Number: 1119421-2026-00296
• Device Sequence Number: 9931115
• Product Code: HQL
• UDI-Device Identifier: 00380655093122
• UDI-Public: (01)00380655093122(17)290404(11)240406(10)25829264
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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.165
• Device Lot Number: 25829264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• 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
• Patient Sex: Unknown