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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.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.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.The manufacturer internal reference number is: (b)(4).

Event Description

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

Manufacturer Narrative

A company cartridge was returned in a self-sealing pouch inside an opened lens carton.Inadequate viscoelastic was observed in the cartridge.The tip was not broken.The tip has stress lines, typical of a lens delivery.The stress lines may have been interpreted by the customer as the reported complaint.The cartridge wings showed evidence of being placed into a handpiece.Compression marks were observed on the front of each locking tab on each wing.This would indicate the handpiece was not a company 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 has stress marks and the stress marks may have been interpreted as the reported complaint.The tip was not broken.The root cause for the reported complaint may be¿related¿a failure to follow the ifu (instructions for use).A non-qualified handpiece was used, and an inadequate amount of viscoelastic was used in the cartridge.Per the ifu: the company cartridges are qualified for use with compatible company 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.An inadequate amount of viscoelastic was observed in the cartridge.The ifu¿instructs¿to completely fill the cartridge with ovd (diagram provided) 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.Stress lines are typical of a lens delivery.While cartridge stress is an expected occurrence and does not denote a cartridge deficiency, stress lines can be more pronounced if there is an inadequate amount of viscoelastic between the lens and the cartridge lumen or if the lens is not positioned correctly.In addition, 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 ; 8175514979
• MDR Report Key: 12836004
• MDR Text Key: 280955658
• Report Number: 1119421-2021-02176
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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
• Date Manufacturer Received: 11/18/2021
• 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 VIVITY TORIC; ASICO ROYAL; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Male