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 Physical Resistance/Sticking (4012)

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

Event Date 10/17/2019

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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, there was resistance and after lens was inserted into the patient's eye, the optic was cracked.The lens was removed and another lens was implanted with no harm to the patient.

Manufacturer Narrative

The cartridge was returned.Viscoelastic is observed in the cartridge.Stress is observed starting in the nozzle on the right side.Heavy stress is observed in the tip.The tip has a large aneurysm on the right side.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was returned in three pieces adhered to the outside of the lens case lid.Cracked areas are observed on one of the returned portions.Associated products indicated are qualified.The root cause for the reported event could not be determined.The observed cartridge damage may indicate the lens/plunger was not in an acceptable position for advancement.The type of cartridge damage observed typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.There are two other complaints in the lot.Corrected information is provided in d.4.And h.10.Additional information was provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 9509007
• MDR Text Key: 177596334
• Report Number: 1119421-2019-02176
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32738586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/17/2020; 01/17/2020
• Supplement Dates FDA Received: 01/07/2020; 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISCOVISC OVD.; MONARCH III IOL DELIVERY SYST.; SN60WF.210, ACRYSOF.
• Patient Age: 72 YR