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 Mechanical Problem (1384)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There has been one other similar complaint 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, more than 10 cartridges of the same lot number used on the same day, had issues with the plunger being hard to push inside the cartridges.Some cartridges were partially shaved by the plunger.There was white thread-like objects confirmed in at least 2 eyes.The surgeries were completed.There were no harm to all of the patients.There are two medical device reports associated with the multiple events reported by this reporter.This report is for the 2 cartridges of the same lot number used on the same day, had issues with the plunger being hard to push inside the cartridges, partially shaved by the plunger and white thread-like object (shavings) that came into 2 eyes.

Event Description

Additional information was provided that 20 cartridges of the same lot number used on the same day, had issues with the plunger being hard to push inside the cartridges and shaved the cartridges.There was white thread-like objects confirmed in at least 8 eyes of 8 identified patients which required removal of the white thread like objects during the procedure.There were no harm to all of the patients.There are 9 medical device reports associated with multiple events reported by this reporter.This report for the 2nd identified patient.

Manufacturer Narrative

The complaint cartridge sample was not returned.Eighty unopened samples for this lot# were returned.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.Specific lens information was provided for this file.The associated 17.0 diopter lens and the indicated handpiece are qualified for use with this cartridge.The viscoelastic indicated is not qualified for use with this cartridge.The root cause for the reported complaint could not be determined 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: 9996228
• MDR Text Key: 189190791
• Report Number: 1119421-2020-00722
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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: 05/07/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6); ASICO INJECTOR (AE-9036SP); OPEGAN-HI; UNSPECIFIED PANOPTIX
• Patient Age: 86 YR