MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number	8065977763
Medical Device Problem Codes	Material Fragmentation (1261); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 8th patient identified.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10164271
• Report Number: 1119421-2020-00878
• Device Sequence Number: 10819282
• Product Code: MSS
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32747370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR