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 Problems Crack (1135); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause cannot been identified.Additional information was requested.(b)(4).

Event Description

A technician reported that during an intraocular lens (iol) implant procedure, the surgeon experienced resistance when lens was being advanced and then the lens jammed and the cartridge cracked.The surgeon used another lens instead with the same handpiece without any problems.The reporter indicated that the viscoelastic had been removed from refrigerator 2 hours prior to surgery and the or temperature runs 67-69f.Additional information was requested.

Manufacturer Narrative

The customer indicated the use of a non-qualified lens in association with the cartridge used.The customer indicated the use of handpiece and non-qualified viscoelastic 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, 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: 7806397
• MDR Text Key: 118104175
• Report Number: 1119421-2018-01186
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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 Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR