MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number	8065977758
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used company cartridge was not returned.The lens was returned wrapped in gauze in a specimen cup.Viscoelastic and blood were observed on the lens.The lens had been cut into two pieces across the center of the optic.One haptic was pulled from the optic, not returned.The lens was cracked in the haptic insertion area of the removed haptic.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model/diopter and handpiece were indicated with a non-qualified viscoelastic.The reported removed haptic was observed.The optic was cracked in the haptic insertion area of the removed haptic.The observed damage may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable intraocular lenses (iols).Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol 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.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).
Event or Problem Description
A facility representative reported with a description of intraocular lens (iol) back haptic ripped.The iol was explanted during initial procedure.Additional information has been requested, received and stated in surgeon's opinion the cartridge caused or contributed to the event.There was no patient harm.

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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: 18694086
• Report Number: 1119421-2024-00267
• Device Sequence Number: 17943374
• Product Code: MSS
• UDI-Device Identifier: 10380659777582
• UDI-Public: 00380659777585
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K001157
• 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): 02/13/2024

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: 01/12/2025
• Device Catalogue Number: 8065977758
• Device Lot Number: 15011950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/13/2024
• Date Device Manufactured: 01/14/2020
• 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: ACRYSOF MULTIPIECE IOL; AMVISC PLUS; ANGLED MCPHERSON FORCEPS; MONARCH II IOL DELIVERY SYSTEM, INJECTOR
• Patient Age: 65 YR
• Patient Sex: Female