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

Catalog Number 8065977763

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

A purchasing person reported that during an intraocular lens (iol) implant procedure, cartridge was broke off into the eye.The doctor was able to locate the piece and removed it from the eye.Additional information has been requested and provided that there was no patient harm and no hospitalization.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The cartridge was returned loose inside a plastic specimen jar.Viscoelastic was observed dried inside the cartridge.The cartridge tip has stress lines.The cartridge has evidence of handpiece use.There are no broken cartridge pieces observed.Another specimen jar was returned with a hard small opaque object floating in clear liquid.This jar has a product sticker applied to it indicating the company lens diopter associated lens.The small opaque colored object in liquid appears to be a broken inner post from the wagon wheel lens case.The lens case of the associated lens was not returned for an evaluation.The file indicated the use of a qualified lens and viscoelastic combination.The handpiece information was not provided.It is unknown if a qualified handpiece was used.The root cause cannot be determined for the reported complaint of "piece of the cartridge broke off into the eye".The returned used cartridge was not broken or torn.A specimen jar was returned with a hard opaque colored object in liquid.The object was identified as a visual match to a broken inner post of a wagon wheel lens case.The lens case for the associated lens was not returned to evaluate.The origin for this broken inner case post of a wagon wheel cannot be confirmed.There is not an opportunity for a broken/damaged post of a lens case to come into contact, co-mingle or be introduced into a cartridge lumen prior to final release from manufacturing facilities.The two products are processed and individually sealed at two completely separate manufacturing facilities (aodc north processes cartridges and aodc south manufactures lenses).These facilities are also physically separated by miles.Per the instructions for use (ifu): to remove the lens, open the pouch and transfer the case to a sterile environment.Carefully open the case to expose the lens.When removing the lens from the case, do not grasp the optical area with forceps.Prior to the actual folding process, the lens should be handled by the haptic portion only.Rinse the lens thoroughly using sterile intraocular irrigating solution such as balanced salt solution (bss) ¿ or bss plus¿ solution.Do not rinse the lens in solution other than sterile intraocular irrigating solution.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• 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: 15713237
• MDR Text Key: 307476754
• Report Number: 1119421-2022-02334
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/01/2022
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE; DUOVISC