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 Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A health professional reported that a small part of the cartridge came off during the preparation portion of a cataract extraction with intraocular lens (iol) implant surgery.There was no patient involved.

Manufacturer Narrative

A company (d) cartridge was returned.Viscoelastic is observed in the cartridge.The cartridge has evidence it was placed into a handpiece.No cartridge damage observed.The particle was returned taped to a side of the company carton.The particle is small and round with a dented/broken end.This appears to be a broken lens case lid pin.It is unknown how this would have been introduced into the cartridge with the lens.The particle did not break off the company cartridge.Product history records were reviewed and the documentation indicated the product met release criteria.The associated iol information was not provided.The indicated handpiece and viscoelastic are not relevant to this complaint.The returned company cartridge is not broken or damaged in any way.The cartridge does show signs of use.The returned particle appears to be a broken lens case lid pin.It is unknown how this would have been transferred with the lens into the company cartridge.Company cartridges are processed in a different facility than iols.The lens case pin could not have originated with the company cartridge.The exact origin of the broken pin cannot be determined.The lens case for the associated iol was not returned.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: 7806081
• MDR Text Key: 118002492
• Report Number: 1119421-2018-01183
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32621099
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• 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