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 Material Rupture (1546)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis and is in transit to the manufacturing site for investigation.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.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during intraocular lens (iol) implant procedure, the cartridge was burst.The patient contact was noted.No patient impact was reported.Additional information has been requested.

Manufacturer Narrative

A company device was returned in a folded and stapled self-sealing pouch inside an opened lens carton.Inadequate viscoelastic was observed in the cartridge.The tip has stress lines beginning in the nozzle and extended into the thinner tip area.The stress line became an aneurysm along the upper right side of the tip.Stress lines were observed on all side of the tip.The cartridge showed evidence of being placed into a handpiece.Photos were provided.Glare in the photos prevented further evaluation.Information was provided that indicated a qualified lens and viscoelastic were used with the cartridge.A non-qualified handpiece was indicated.The tip was heavily stressed beginning in the nozzle and extending into the tip.A long aneurysm formed at the tip.The root cause for the reported complaint may be related to a failure to follow the ifu.A non-qualified handpiece was used, and an inadequate amount of viscoelastic was used in the cartridge.Per the ifu: the company device are qualified for use with compatible company device handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu instructs to fill the cartridge with viscoelastic before loading the lens.Damage may occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; or if the handpiece plunger is not positioned correctly at the trailing optic edge.The cartridge damage began in the thick nozzle cone wall on the anterior and travelled to the thinner tip area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced and not an immediate ¿burst¿ event, unless the lens was advanced at a very fast rate.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.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: 12842821
• MDR Text Key: 281026195
• Report Number: 1119421-2021-02179
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/15/2021
• 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 VIVITY TORIC EXTENDED VISION IOL; ASICO HANDPIECE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Male