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

Model Number AU00T0

Device Problem Insufficient Information (3190)

Patient Problems Rupture (2208); Vitrectomy (2643)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

A sample is in transit to manufacturing site.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Several attempts to obtain additional information have been made with no response to date.The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmic surgeon reported that during a cataract surgery with intraocular lens (iol) implant, the surgeon had to remove the lens from the eye after implantation.The first haptic came out oriented downwards, towards the capsule and therefore the surgeon did not completely push the piston.The second haptic entered the eye nonetheless.The iol had to be positioned again in order to place it in the bag.The second haptic was still folded.A capsular rupture occurred on 180 degrees.The surgeon had to remove the iol in order to proceed to a vitrectomy.Several attempts to obtain additional information have been made with no response to date.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: product evaluation: the device was returned loose in the carton.Viscoelastic is dried in the device.The plunger is oriented correctly.The lens was returned adhered to the outside of the loading area door.No damage or abnormalities are observed.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic used was not provided.It is unknown if a qualified viscoelastic product was used in the device.The root cause for the complaint of leading haptic implanted downward, bag broken by trailing haptic could not be determined.The lens was returned outside of the device.No abnormality or damage was observed.A straight leading haptic is an acceptable position per the dfu and is not a malfunction of the lens/device.The dfu instructs if the leading haptic is straight or looped and extended in front of the lens, rotate device to be bevel left before advancing plunger to ensure the leading haptic is correctly placed in the capsular bag.As the leading haptic begins to exit the nozzle tip, place the leading haptic into the capsular bag in its correct orientation, and continue to slowly advance the plunger to deliver the lens.As the optic exits the nozzle, rotate the device back to center or slightly bevel right if needed to ensure the lens unfolds anterior side up within the capsular bag.(b)(4).

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5302487
• MDR Text Key: 33641590
• Report Number: 1119421-2015-06856
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.235
• Device Lot Number: 12404399
• Other Device ID Number: 00380652358347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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; Required Intervention