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 Contamination /Decontamination Problem (2895)

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

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Monarch complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been 12 similar complaints in this lot.(b)(4).

Event Description

A physician reported that a foreign material was found to be adhered to the backside of the intraocular lens (iol) after implanting; this was noted in three cases.The foreign material was able to be removed by aspirating with the irrigation and aspiration.The surgery was completed and the lenses remain implanted.There are multiple reports for this event, this represents the cartridge for patient (b)(6) and additional reports will be filed.

Manufacturer Narrative

The used cartridge complaint sample was not returned.A video was provided.The cartridge preparation was not shown.Viscoelastic amount could not be determined.The lens was loaded with narrow tip forceps.A different set of forceps was used to rapidly advance the lens in the cartridge.The cartridge tip was inserted into the incision.The lens was rapidly advanced from mid-nozzle into the eye.After the lens unfolds, a strip of material was observed on the right side of the posterior surface.The material was removed with the i/a tip.The lens remained implanted.The associated lens model/diopter indicated is qualified for use with the cartridge.A non-qualified handpiece/viscoelastic combination was indicated.Root cause: the root cause for the reported foreign material could not be determined.The used cartridge was not returned.No determination can be made without physical evaluation of the complaint sample.The provided video was reviewed.A strip of material was observed on the posterior surface.Based on the review of the provided video, the observed material may have been internal coating material from the cartridge.A non-qualified handpiece/viscoelastic combination was indicated.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: 10657740
• MDR Text Key: 211004403
• Report Number: 1119421-2020-01434
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 32751148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP; OPEGAN; SN60WFA205, ACRYSOF SP NATURAL IQ, HWV
• Patient Outcome(s): Required Intervention