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 Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In a journal article, non healthcare professional reported that during a cataract extraction with intraocular lens (iol) implant procedure, the surgeon noted the presence of a crust on one of the haptics and the optic.It was not possible to remove this material from the iol surface by irrigation/aspiration.The lens was bisected for explantation and exchanged for another lens.The patient was last seen at the 6-month visit with 20/25 uncorrected visual acuity.Slit lamp examination was unremarkable at that time.It was reported that ophthalmic viscosurgical device (ovd) precipitation might have occurred in the case reported here under different circumstances, after lens loading into the injector, or immediately after injection of the lens into the eye.Residues from cartridges coating are also a possibility.There are two medical device reports associated with this article.This report is for 2nd report out of 2 reports.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Literature article : ms hickman, l werner, n mamalis, e sung, d goldstein, dt vroman and sk pandey.Intraoperative explantation of two single-piece hydrophobic acrylic intraocular lenses due to surface deposits.Eye (2006) 20, 1054¿1060.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.Correction information provided in e.1.The product was not returned.Complaint history and product history records could not be reviewed because the literature report did not provide a lot number or any identification traceable to the manufacturing documentation.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.This complaint was opened from a 2005 literature report: intraoperative explantation of two single-piece hydrophobic acrylic intraocular lenses due to surface deposits.Review of the provided photos appear to show deposits on the surface of the lenses.These deposits cover a large surface area of each lens and have the appearance of dried ophthalmic viscosurgical devices (ovd) or other solution.The ¿deposits¿ do not appear to be lens damage or related to the cartridge.The report indicated that surface analyses performed on the material observed intraoperatively by the surgeons only demonstrated the presence of elements that may be normal components of different ovd preparations.The report further indicated that ¿hypothetically, although the analyses performed were not conclusive, ovd precipitation might have occurred in the cases reported here under different circumstances, after lens loading into the injector, or immediately after injection of the lens into the eye¿.The manufacturer internal reference number is: (b)(4).

• 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: 15924263
• Report Number: 1119421-2022-02577
• Device Sequence Number: 6689763
• Product Code: MSS
• UDI-Device Identifier: 10380659777582
• UDI-Public: 00380659777585
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K001157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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 Catalogue Number: 8065977758
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 SINGLEPIECE IOL; HEALON; MONARCH II INJECTOR
• Patient Age: 64 YR
• Patient Sex: Female