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

Model Number	MA60AC
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported with a description of the surgeon wasn¿t happy with the way the intraocular lens unfolded in the eye and decided to explant it and put a new one in.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified associated cartridge and handpiece.Two viscoelastics were indicated only one is qualified for the lens company model combination used.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.The product has not been received to evaluate.It is unknown if qualified product combination was used.The instructions for use (ifu) instructs company foldable intraocular lens (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical 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).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 19583597
• Report Number: 1119421-2024-01192
• Device Sequence Number: 7317839
• Product Code: HQL
• UDI-Device Identifier: 00380652552493
• UDI-Public: (01)00380652552493(17)250318(11)200319(10)15058119(21)15058119014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 03/18/2025
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.185
• Device Lot Number: 15058119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Date Device Manufactured: 03/19/2020
• 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: DUOVISC OVD.; MONARCH II IOL, CARTRIDGE B.; MONARCH III IOL, INJECTOR.
• Patient Sex: Unknown