MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA60AC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
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 non-healthcare professional reported that during the intraocular lens (iol) implantation procedure, a small capsular tear was noted after removal of the nucleus and epinucleus.The tear extended during cortex removal, and the surgeon decided to implant a sulcus lens.It appeared that the leading haptic was placed posterior to the sulcus space.During manipulation of the lens, it became entangled in the pupil expansion device (ring), which resulted in one of the haptics becoming bent.The lens was cut and removed from the eye, and another lens was implanted on the same day.Some vitreous was noted in the anterior chamber, and an anterior vitrectomy was successfully performed.Post operative visits have revealed no further vitreous in the eye, and the patient is being monitored according to the post operative schedule.No initial defect was noted with the lens.
Additional Manufacturer Narrative
The sample was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified cartridge and handpiece were used with a non-qualified viscoelastic.The product was not returned.The questionnaire indicated that there was no initial defect noted with the lens.The root cause of the reported bent haptic that occurred may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was used.The ifu instructs: company specific foldable iols (intraocular lens) are qualified for use with a company specific qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company specific qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The completed questionnaire indicated that per the surgeon's operative note, it appears that there was a small capsular tear noted (after removal of the nucleus and epi-nucleus).The tear extended with removal of the cortex, and the surgeon decided to implant a sulcus lens.It appears that the leading haptic was placed posterior to the sulcus space and, with manipulation of the lens, the lens ¿became entangled¿ in the malyugin ring, which lead to one of the haptics getting bent.The lens was cut and removed from the eye, and another lens was placed the same day.Some vitreous was noted in the anterior chamber and an anterior vitrectomy was performed with success.Post-op visits have revealed no more vitreous in the eye.Monitored per post-op schedule.Due diligence has been performed in an attempt to obtain further information on this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23626965
• Report Number: 1119421-2025-03003
• Device Sequence Number: 16071676
• Product Code: HQL
• UDI-Device Identifier: 00380652552561
• UDI-Public: (01)00380652552561(17)261127(11)211129(10)15310915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.220
• Device Lot Number: 15310915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 11/29/2021
• 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: ACRYSOF MULTIPIECE IOL.; HEALON PRO J&J.; MALYUGIN RING.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male