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

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 healthcare professional reported that during a cataract surgery with an intraocular lens (iol) implant procedure, the lens was seen fractured at the corner of the helix at the time of implantation.There was no patient contact.The surgery was completed on the same day with an unspecified lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol).Iol returned positioned correctly in the lens case.Solution is dried on the iol.One haptic tip is missing, the other haptic is intact.The optic is scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "the lens was seen fractured at the corner of the helix".The reported complaint is lacking in relevant information regarding clarification on the associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed broken haptics would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information was provided in h11.The product was returned for analysis, and the reported complaint was observed.Intraocular lens (iol) returned positioned correctly in the lens case.Solution is dried on the iol.One haptic tip is missing, the other haptic is intact.The optic is scratched/marked-rejectable.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.Additional information: the complainant indicates the use of universal 1.5% viscoelastic.It is unclear if this is a brand name or a generic statement regarding ophthalmic viscosurgical devices (ovds).The root cause for the reported complaint could not be determined.The product was subject to handling - the iol was returned with solution dried on it.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.In addition to this, all iols are 100% percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.The reporter states the use of "universal 1.5% viscoelastic".It is unclear if this is a brand name or a generic statement regarding ovds.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 20570300
• Report Number: 9612169-2024-01108
• Device Sequence Number: 7481118
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: (01)00380655093177(17)281114(11)231117(10)25758407
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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.190
• Device Lot Number: 25758407
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 07/11/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/30/2024; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNIVERSAL 1.5% VISCOELASTIC
• Patient Sex: Female
• Patient Weight: 65 KG