MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; LENS, GUIDE, INTRAOCULAR

Model Number ASKU

Device Problems Scratched Material (3020); Unintended Movement (3026)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: no injector (unspecified injector) was returned for evaluation for the report of the lens being scratched with the lens removed; therefore, the condition of the product could not be verified.A backup lens was used with no problems.No injector lot number was identified with this complaint; therefore, a lot history review could not be conducted.A photo was provided which contained a small label with lens information.Because an injector sample was not returned and no injector lot information was provided, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during a cataract extraction/intraocular lens(iol) implant procedure, the loader seemed to push over the lens which ended up scratching the centre of the iol.The loader was retracted and a second attempt was made to introduce the lens into the end of the cartridge, however, it once again moved over the surface of the iol.When the lens was implanted in the patient's eye it had a visible scratch down the centre and that is when the surgeon decided to remove the lens and implant the second one available.Additional information was requested.

Manufacturer Narrative

(b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7183642
• MDR Text Key: 97659411
• Report Number: 2523835-2018-00020
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other