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 Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that during a cataract extraction with intraocular lens implant (iol) procedure, foreign material in the shape of thread was seen behind the optic, facing posterior capsule when the cartridge was used to insert.They thought it was a scratch on the iol but it was removable by hook.The surgery was then completed.The issue occurred in three cases using the cartridge having the same lot number in the same box.Such issue was not seen in cases where a different lot of a different box was used.Additional information was requested.

Manufacturer Narrative

Product evaluation: the complaint cartridges were not returned.One unopened cartridge was returned for a different lot number.The returned unopened cartridge was functionally evaluated.No lens or cartridge damage was observed, after the lens delivery.No foreign material was observed.The returned unopened cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed, and documentation indicated the product met release criteria.A non-qualified, non company lens and viscoelastic were indicated.The root cause for the reported complaint could not be determined.The used cartridge complaint samples were not returned.No determination can be made without physical evaluation of the complaint sample.One unopened cartridge returned for the reported lot was evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened sample with acceptable results.No foreign material was observed, after the functional testing.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: 12101140
• MDR Text Key: 259446340
• Report Number: 1119421-2021-01302
• 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: 32761895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/15/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL ZCB00; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OVD: OPEGAN-HI; UNSPECIFIED HOOK; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED HOOK