MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number AU00T0

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Complaint history and product history records could not be reviewed because the reporting 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 surgeon reported that he feels that the nozzle of the preloaded intraocular lens (iol) delivery system does not go far enough into the wound and does not completely fit into a 2.4mm wound.The surgeon further explained that quite often during insertion the lens will push the nozzle back out of the wound and the lens will become stuck in the wound.The surgeon also stated that there is a lot of pressure needed on the outside of the eye with the depth guard, which ends up pushing the eye away from him and he has to insert the lens ¿blind¿ [i.E.He cannot see the anterior chamber (ac) anymore through the microscope and the lens goes into the ac while the eye has rotated away from him].Similarly, the surgeon also reported that on occasion the pressure needed on the plunger to get the lens through the device is significant and makes him feel uncomfortable that it will ¿give way¿.This is one of two medical device reports for this facility.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 7136299
• MDR Text Key: 95744645
• Report Number: 1119421-2017-01448
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2017

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: AU00T0
• 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: 11/26/2017
• Initial Date FDA Received: 12/20/2017
• 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