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

Catalog Number 8065977763

Device Problem Break (1069)

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

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

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.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A facility representative reported that when the surgeon loaded an intraocular lens (iol) into the cartridge, the haptic was broken.Additional information was received by the surgeon indicating that the iol began breaking while loading, and completely broke after pushing it to the end of the cartridge.

Manufacturer Narrative

The cartridge was returned inside a folded peel pouch.Only a residue of viscoelastic was observed in the cartridge loading area.The cartridge tip has slight stress lines.The cartridge wings show evidence of being placed into a handpiece.Cartridge product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified lens model.The iol product history records were reviewed and the documentation indicated the product met release criteria.Handpiece and viscoelastic information was not provided.It is unknown if qualified associated products were used.The smashed tabs observed on the wings of the cartridge would indicate that the lens had been loaded into the cartridge and the lens/cartridge combination was then securely placed into the locking slots of the handpiece.Broken haptic damage was observed on the associated iol.Based on the evaluation of the cartridge and the associated returned lens, the root cause of the complaint for "broken haptic during loading" may be related to a failure to follow the dfu.Only a slight residue of a viscoelastic was observed in the cartridge.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.(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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7843823
• MDR Text Key: 119346580
• Report Number: 1119421-2018-01245
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2018

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32615896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other