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

Catalog Number 8065977762

Device Problem Break (1069)

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

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Cartridge product history records were reviewed and documentation indicates the product met release criteria.There have been no other complaints reported in the lot number.The iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.A root cause has not been identified.(b)(4).

Event Description

A physician reported that during the lens implantation portion of a cataract removal with intraocular lens (iol) implant procedure, the cartridge broke, and the iol "shot out", leading to a posterior capsule defect.The procedure was able to be completed successfully.The health and sight of the patient was not impaired; the event reportedly resolved with treatment.Additional information has been requested.

Manufacturer Narrative

The facility indicated the use of a 33.0 diopter iol.The highest qualified diopter range for the reported cartridge is 30.0.The most likely root cause is a failure to follow the directions for use (dfu).The cartridges are qualified with iols for specific diopter ranges.A 33.0 diopter iol is not qualified for use with the reported cartridge.The use of non-qualified product combination may lead to damage and/or delivery issues.The following information was also provided: after a small training on "which cartridge is suitable for which lens/diopter" the team (of the hospital/initial reporter) considers this issue as completed.They used cartridges that were too small for higher lens strengths, but are now satisfied with the correctly ordered cartridges.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7135888
• MDR Text Key: 95447351
• Report Number: 1119421-2017-01446
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065977762
• Device Lot Number: 32553736
• Other Device ID Number: 00380659777622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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