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 Problems Defective Device (2588); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The used company cartridge was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model/diopter was indicated with a company handpiece (model not provided).The viscoelastic indicated is not qualified.The company cartridge complaint product was not returned for evaluation.The root cause for the reported complaint may be related to a failure to follow the ifu (instructions for use).The viscoelastic indicated is not qualified for the lens/cartridge combination used.The ifu (instructions for use) 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 (instructions for use) instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu (instructions for use) also instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical devices) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd (ophthalmic viscosurgical devices) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd (ophthalmic viscosurgical devices), which may result in damage.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was mounted on the cartridge in the company injector.At the time of insertion, it was noticed that it was a little harder than normal.Doctor saw this and removed the cartridge from the eye, the lens was seen at the tip of the cartridge which when observed it under a microscope he could see that the cartridge was all open and when removed the lens it was appreciated that the lower haptic was broken.Additional information was received stating procedure was not completed during the surgery and the patient was scheduled for lens implantation in a second surgery.There was no patient harm and patient was not hospitalized as a result of this event.Additional information was received stating patient's lens implantation was performed in a second surgery.Patient was fine and with a very satisfactory recovery.

Manufacturer Narrative

The used cartridge for the reported lot was evaluated.Inadequate viscoelastic was observed.Viscoelastic was observed only at the nozzle entry.Large internal scrape marks were observed on the top and bottom of the nozzle that extended into the tip.The cartridge tip also has a large aneurysm on the bottom and heavy stress.The aneurysm had torn.The cartridge had evidence of placement into a handpiece.Top coat dye stain was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.The indicated lens model and handpiece were qualified.The viscoelastic indicated was not qualified.The root cause for the reported broken haptic may be related to a failure to follow the ifu.The viscoelastic indicated is not qualified for the lens/delivery system combination used.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.Inadequate viscoelastic was also observed.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The extensive cartridge damage may indicate damage to the handpiece.This type of damage may also occur if the lens/plunger are not in acceptable positions for advancement along with an inadequate amount of ovd.The ifu instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.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: 16476388
• MDR Text Key: 310586320
• Report Number: 1119421-2023-00386
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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: 8065977763
• Device Lot Number: 15496111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/04/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL.; HILURON 1.8%.; MONARCH, INJECTOR, UNSPECIFIED.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female