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 Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Cartridge product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.There has been one other similar complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A certified ophthalmic assistant cot) reported that during an intraocular lens (iol) implant procedure, the cartridge tip split when inserting the iol.There was contact with the patient.Additional information was provided that there was no patient harm.The implant did not go into the eye properly; it came out the side of the cartridge instead of going into the eye.The temperature of the operating room was 68 degrees.The temperature of the viscoelastic was 68 degrees.

Manufacturer Narrative

Product evaluation: a used cartridge was returned in an opened pouch.Viscoelastic is observed in the cartridge.The nozzle is cracked and split on the right side.The tip has heavy stress and is split on the right side.The interior of the cartridge is scraped on the floor where the cracked damage is observed.The cartridge has evidence it was placed into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The provided associated products are qualified for use with this cartridge.The root cause for the tip damage could not be determined.The damage to the nozzle started in the thick wall cone area of the nozzle.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
• MDR Report Key: 8708125
• MDR Text Key: 148548823
• Report Number: 1119421-2019-00949
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32671499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM; SA60WF 24.0D
• Patient Age: 68 YR