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

Catalog Number 8065977763

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A doctor reported that during an intraocular lens (iol) implant procedure, the cartridge tip broke.The patient was involved but there was no harm to the patient.The procedure was completed.

Manufacturer Narrative

Corrected information was provided.Additional information was provided.The used cartridge was returned.Viscoelastic is observed in and on the outside of the cartridge.The cartridge has evidence it was placed in a handpiece.The evidence would suggest cartridge was not fully seated in the handpiece or a non-qualified handpiece was used.An aneurysm is observed in the thick wall of the nozzle behind the parting line.The aneurysm leads into a split as it advances into the tip area.The lens, handpiece and viscoelastic used were not provided.It is unknown if a qualified combination was used.A 25.0 diopter lens was indicated.The qualified diopter range is specific per model.Certain models for the cartridge are not qualified up to a 25.0 diopter.The iol product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The reported cartridge damage was observed.This type of damage is typically progressive and worsens as the lens is advanced.The damage on the top of the nozzle started in the thick wall cone area of the nozzle.Unusually high internal forces would be needed to create damage in this area.This type of damage typically occurs if the lens or plunger is not positioned correctly for advancement.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7631399
• MDR Text Key: 112294969
• Report Number: 1119421-2018-00798
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 8065977763
• Device Lot Number: 32532890
• Other Device ID Number: 380659777639
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other