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	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is bent three times in the gusset and distal areas.The lens is cut in half, typical of insertion and removal from the eye.A batch 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 medical device file were met.The file indicates the use of a qualified cartridge and handpiece.A viscoelastic was used that is not qualified for this lens.Haptic damage was observed.The root cause for the reported complaint may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens/company combination used.Company foldable intraocular lens (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device unspecified viscoelastic (ovd) combination.The instructions for use (ifu) instructs that an 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.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 millimeter 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the haptic was bent.Following this, an unplanned vitrectomy was performed, where the exchanged intraocular lens occurred and was sutured in place.Additionally, the suture was placed at the incision site as well.Additional information has been requested but is not available at the time of this report.

• 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: 25632840
• Report Number: 1119421-2026-01342
• Device Sequence Number: 9553117
• Product Code: HQL
• UDI-Device Identifier: 00380652552462
• UDI-Public: (01)00380652552462(17)260519(11)210521(10)15204421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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 Expiration Date: 05/19/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.170
• Device Lot Number: 15204421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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; DISCOVISC OVD; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM 2000
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male