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 Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the complaint cartridge samples were not returned.Eighty unopened samples for this lot# were returned and has been separated into eight individual complaints per provided individual patient information.One sample was pulled randomly from each returned carton and numbered 1-8 for evaluation purposes.The cartridges were visually examined with no abnormalities observed.Functional and dye stain testing was conducted with acceptable results.No lens or cartridge damage was observed.No foreign material was observed on the lenses post-delivery.No resistance was felt during advancement.The cartridge product history records were reviewed and the documentation indicated the product met release criteria.The indicated competitor's lens, handpiece and viscoelastic are not a qualified combination for use with this cartridge.The root cause for the reported complaint could not be determined.There has been 8 other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during multiple cataract surgeries with intraocular lens (iol) implantations, cartridges of the same lot number used on the same day, had issues with the plunger being hard to push inside the cartridges.The cartridges were partially shaved by the plunger.There was white thread-like objects confirmed in 8 eye that were removed from the eye during the procedures.The surgeries were completed.There were no harm to all of the patients.There were two medical device reports previously reported under mfg report num.1119421-2020-00723 and 1119421-2020-00722 associated with the multiple events reported by this reporter.Seven additional medical device reports will be submitted for the identified patients.This report is for the 7th patient identified.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10164171
• MDR Text Key: 196393345
• Report Number: 1119421-2020-00877
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2020

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 Catalogue Number: 8065977763
• Device Lot Number: 32747370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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 Age: 76 YR