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 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and 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 product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A lead technician reported that during a cataract surgery with an intraocular lens (iol) implantation, the "cartridge broke with lens inside".There was patient contact.The procedure was completed.Additional information was provided for the issue of the broken cartridge with the jammed lens indicating that there was no patient harm.There was no impact to the cartridge tip.The iol was cracked as well.The operating room temperature was 69 degrees.

Manufacturer Narrative

Evaluation summary: the cartridge was returned with the lens in the tip.Inadequate viscoelastic was observed in the cartridge.The lens is misfolded, pressed up against the roof of the cartridge.The trailing haptic is misfolded under the optic.The tip of the cartridge is split along the top and has heavy stress.This lens/haptic position and the damage are indicative of a plunger underride.The indicated associated products are qualified.The root cause for the lens and cartridge damage appears to be related to a failure to follow the directions for use (dfu).The lens was not biased down.It was misfolded pressed up against the roof of the cartridge.The trailing haptic position misfolded under the optic is an indication that haptic was not placed on the anterior surface when loaded.It is also an indication that a plunger underride occurred.In addition, there appeared to be an inadequate amount of viscoelastic.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: 9774383
• MDR Text Key: 184732251
• Report Number: 1119421-2020-00348
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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: 03/03/2020
• Date Manufacturer Received: 04/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCPHEARSON FORCEPS; MONARCH III IOL DELIVERY SYST; SA60WF.205; UNSPECIFIED PROVISC OVD
• Patient Age: 79 YR