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 Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2021

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 complaint reported in the lot number from the same facility.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during multiple cataract extraction procedures with intraocular lens (iol) implantations a foreign material like a long thin object was seen behind the iols.The physician alleges that the cartridges were likely scratched in the course of iol insertion.No patient harm has been reported for the time being.The foreign materials were almost completely removed during the initial surgeries in all cases.The surgeries were completed without product replacement.Additional information has been provided indicated that there was no harm/ problem to all patients.Additional procedures and treatments will not be needed since the foreign materials have been removed by irrigation and aspiration in the initial surgery.There are two medical device reports associated with the multiple events reported that occurred on two different dates.This report is for the events that occurred on (b)(6) 2021.

Manufacturer Narrative

Additional information was provided in d.9., h.3., h.6.And h.10.Evaluation summary: six used cartridges were returned with three unopened cartridge 10-count cartons for lot # reported.Two of the six returned used cartridges did not exhibit an adequate amount of viscoelastic.All six used cartridges had evidence of placement into a handpiece.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Four of the returned used cartridges had damage with internal disruption in the coating of the tip.The remaining two used cartridges had no damage.Three of the returned, unopened cartridges were opened for evaluation (1 from each carton).No damage or foreign material was observed.The unopened cartridges were functional and dye stain tested.No lens or cartridge damage or foreign material was observed after the lens deliveries.Top coat day stain testing was conducted with acceptable results.The provided video was reviewed.The cartridge and lens preparation were not shown.The lens was rapidly advanced into the eye.A linear foreign material was observed (posterior), which was removed with the irrigation aspiration i/a tip.The lens remained implanted.A qualified lens model was indicated.It is unknown if the lenses were in the qualified diopter range.A qualified viscoelastic was indicated with a non-qualified handpiece.The root cause for the reported issue could not be determined.Based on the review of the returned video and the returned used cartridges, the reported foreign material may have been internal coating material from the damaged cartridge tips.Three of the returned unopened cartridges were evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.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: 12100836
• MDR Text Key: 259432398
• Report Number: 1119421-2021-01299
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• 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: 07/28/2021

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: 15097711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 07/17/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL; AE-9063CSP; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; ACRYSOF IQ NATURAL SINGLEPIECE IOL; AE-9063CSP; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE