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

Model Number AU00T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Detachment (2445); Capsular Bag Tear (2639)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

Lens remains implanted, but the injector portion of the device is in transit to manufacturing site.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information was requested.(b)(4).

Event Description

A nurse reported that after an intraocular lens (iol) was inserted into a patient's eye, there was vitreous at the anterior chamber.The surgeon indicated that the haptic scratched the capsule causing it to tear.The surgeon implanted the lens into the sulcus.Additional information was requested.

Manufacturer Narrative

Lens was never implanted.The product of injector and lens was returned for analysis.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.(b)(4).

Event Description

Upon review of reported data and sample received, it was determined that the lens associated with the report was not implanted.It was sent back for analysis and a back up lens had been implanted into sulcus during the initial surgical procedure.

Manufacturer Narrative

The device and the lens were returned.The plunger is oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to the mid-nozzle.The lens was returned taped to inside of the blister tray.The optic has been cut into three pieces (typical of a removal).Both haptics are intact.No haptic damage or abnormalities are observed.Viscoelastic was not provided.It is unknown if the qualified product was used.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause could not be determined for the reported capsule tear.The lens had been cut for removal.The haptics were intact and no abnormalities were observed.No problems were observed with the returned device.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6697671
• MDR Text Key: 79506729
• Report Number: 1119421-2017-00878
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P930014
• 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,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.215
• Device Lot Number: 12462461
• Other Device ID Number: 00380652358309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• 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