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 Detachment Of Device Component (1104)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: 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 has not been identified.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that a trailing haptic of a lens detached due to the cartridge during an intraocular lens (iol) implant procedure.The lens was removed and replaced during the initial procedure.

Manufacturer Narrative

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

Event Description

The postoperative outcome for the patient was fine, no problems were associated.

Manufacturer Narrative

Additional information provided.The customer indicated the use of a non-qualified 27.5 diopter lens.Iol product history records were reviewed and the documentation indicated the product met release criteria.The lens is only qualified to be used with a specific cartridge if it is within the diopter range of 6.0 to 27.0.The root cause is most likely related a failure to follow the directions for use (dfu) the account used a non-qualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.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: 7350175
• MDR Text Key: 103010984
• Report Number: 1119421-2018-00288
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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
• Other Device ID Number: 00380659777639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2018
• 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: 81 YR