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

Catalog Number 8065977758

Device Problems Particulates (1451); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Edema (1791)

Event Type  Injury  

Event Description

In a journal article, non healthcare professional reported that during a cataract extraction with intraocular lens (iol) implant procedure, the physician noted that it was difficult injecting the lens into the eye with a crunching sound.Upon insertion, a white, granular material was noted immediately on the lens and in the anterior chamber.Attempts to remove this material by irrigation and aspiration were only partially successful.The lens was then cut in half with scissors and removed.Vigorous irrigation and aspiration was used to remove the remaining ophthalmic viscosurgical device (ovd) and the white, granular material from the capsular bag.Some of this material was noted in the clear corneal wound, which could not be removed.Another same model lens was then injected into the bag.Postoperatively, the patient initially developed corneal edema at 1 week.At 1 month postoperatively, the last time the patient was seen, the eye was quiet, the corneal edema had resolved.It was reported that ophthalmic visco surgical 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 1st report out of 2 reports.

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.Ms hickman, l werner, n mamalis, e sung, d goldstein, dt vroman and sk pandey.Intraoperative explanation 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).

Manufacturer Narrative

Additional information was provided in sections h.6., and h.10.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.Qualified associated products were indicated.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 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¿.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Type of Device: 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: 15884921
• MDR Text Key: 304506649
• Report Number: 1119421-2022-02522
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777585
• UDI-Public: 00380659777585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065977758
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL; MONARCH II IOL DELIVERY SYSTEM, INJECTOR; VANNAS SCISSORS; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male