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

Model Number	MN6AD1
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
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 facility representative reported that during an intraocular lens (iol) implant procedure, upon lens insertion, the haptic was outside of the eye.When maneuvered the haptic broke.Subsequently the lens was removed during initial procedure.Additional information received stating that broken trailing haptic.The procedure was completed on same day.In the surgeons opinion product contributed to event.There was no patient harm.
Additional Manufacturer Narrative
Correction: in initial mdr the product problem code a040609 was reported in error.The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.One haptic was pulled from the optic (not returned).Product history records were reviewed, and the documentation indicated the product met release criteria.Qualified associated products were indicated.The reported broken haptic was observed.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The instructions for use (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 ophthalmic viscosurgical devices (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.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ RESTOR MULTIPIECE IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20612978
• Report Number: 1119421-2024-02149
• Device Sequence Number: 8792438
• Product Code: MFK
• UDI-Device Identifier: 00380652262934
• UDI-Public: (01)00380652262934(17)251214(11)201215(10)15121327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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 Expiration Date: 12/14/2025
• Device Model Number: MN6AD1
• Device Catalogue Number: MN6AD1U140
• Device Lot Number: 15121327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: MCPHEARSON FORCEPS; MONARCH II IOL, CARTRIDGE A; MONARCH III IOL, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 64 YR
• Patient Sex: Male