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

Model Number	MA60MA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens (iol) was returned for evaluation.Ophthalmic viscosurgical device (ovd) is dried on the lens.Both haptics is broken in the distal area with only one of the broken haptics returned loose in the lens case.Both haptics is bent in the gusset area.The iol is cut in half, typical of insertion and removal from the eye.One half of the optic is split on the edge.A device 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.The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the haptic got crimped during insertion.The lens was explanted during initial procedure.The procedure was completed on same day.There was no impact to the patient additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
Correction information was provided in d.9.And h.11.The lens was returned for evaluation.Solution is dried on the lens.Both haptics are broken in the distal area with only one of the broken haptics returned loose in the lens case.Both haptics are bent in the gusset area.The lens is cut in half, typical of insertion and removal from the eye.One half of the optic is split on the edge.A device 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.The file indicates the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/monarch combination used.Company foldable iols (intraocular lens) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic visco surgical device (ovd) combination.The ifu instructs that a company 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 ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.Lenses with a 6.5 mm optic diameter may need to be pre-folded for easy entry into the back of the cartridge.Lens may be pre-folded by gently applying pressure to the edge of the lens while holding the central optic with forceps.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.The manufacturer internal reference number is: (b)(4)2025.

• 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: 23450824
• Report Number: 1119421-2025-02835
• Device Sequence Number: 9040336
• Product Code: HQL
• UDI-Device Identifier: 00380650699275
• UDI-Public: (01)00380650699275(17)270521(11)220523(10)15412053
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/01/2025

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: MA60MA
• Device Catalogue Number: MA60MA.040
• Device Lot Number: 15412053
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 II IOL DELIVERY SYSTEM, CARTRIDGE A; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOELASTIC - ANIKAVISC
• Patient Age: 42 YR
• Patient Sex: Female