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 Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A physician reported that a stretchy material similar to a piece of rubber (not a string or fibrous) material was attached to the backside of the lenses.The surgeon implanted lens with the same issue and did not remove the extra material.There was patient contact.Additional information was received and stated that it was scheduled to be explanted.

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

A company(d) cartridge was returned in a biohazard bag.The lens was returned in a specimen cup inside another biohazard bag.The returned company(d) cartridge was evaluated.The cartridge had no signs of use.There was no ovd visible in the returned cartridge.The cartridge had no evidence of placement into a handpiece.No damage or abnormalities were observed.Top coat dye stain testing was conducted with acceptable results.This does not appear to be the cartridge used to implant the lens.The lens was removed from the specimen cup for evaluation.The lens was returned cut into two pieces typical of a removal.Both optic portions had a large amount of dried viscoelastic.One optic portion had two areas, which appeared to correspond to the provided photo.Unable to determine if this was dried ovd or another material.This portion of the lens was sent to the lab for identification testing of the observed material.Lab results, the clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be monarch cartridge material.A qualified lens model/diopter was indicated with a non-qualified viscoelastic.The handpiece used was not provided.It is unknown if a qualified handpiece was used.The root cause for the material on the lens could not be determined.The returned, loose company(d) cartridge had no signs of use.There was no ovd visible in the returned cartridge.The cartridge had no evidence of placement into a handpiece.No damage or abnormalities were observed.Top coat dye stain testing was conducted with acceptable results.This does not appear to be the cartridge used to implant the lens.A root cause determination cannot be made without physical examination of the used company cartridge.The root cause may be related to a failure to follow the ifu.A non-qualified viscoelastic was indicated.It is unknown if a qualified handpiece was used.The clear material observed on the lens was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be monarch cartridge material, not coating material.The results would indicate the cartridge was damaged/scraped during the lens delivery.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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 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 ifu instructs: using holding forceps, 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 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.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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: 18204812
• MDR Text Key: 328920195
• Report Number: 1119421-2023-02008
• 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
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/23/2024
• 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: CLAREON TORIC UV ABSORBING IOL.; HEALON PRO.
• Patient Age: 71 YR
• Patient Sex: Male