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

Model Number AU00T0

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

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The device and the lens were returned separated.The plunger is oriented correctly.A large amount of viscoelastic is observed in the device and on the outside of the door.Viscoelastic is also observed in and on the outside of the barrel.The plunger has been retracted to mid-nozzle.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was adhered to the extra label set with viscoelastic.The lens was cleaned with lphse.The optic is scratched on the posterior surface.The lens dimensions are acceptable (plan view) using an approved template.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.The root cause for reported difficulty cannot be determined.The plunger and lens position during delivery cannot be determined.The lens was scratched on the posterior surface.This damage may indicate a plunger underride.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.There are no other complaints in the lot.Additional information was not received.The manufacturer internal reference number is: 2018-36390.

Event Description

A physician reported that during an intraocular lens (iol) implant procedure the lens was delivered outside of the wound.There was no reported patient impact.No other information was provided.

Manufacturer Narrative

A qualified viscoelastic was indicated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7581146
• MDR Text Key: 110766711
• Report Number: 1119421-2018-00726
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: AU00T0
• Device Lot Number: 12530304
• Other Device ID Number: 00380652358378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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