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

Model Number AU00T0

Device Problem Sticking (1597)

Patient Problem Inflammation (1932)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

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.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during a cataract removal with intraocular lens (iol) implant procedure, he observed that the syringe delivery was very stiff; it was not smooth as expected.This resulted in needing to apply more pressure which caused the lens to eject from the device in an uncontrolled manner.There were no long term adverse effects.Additional information was provided, indicating that a few hours after the surgery, the patient presented with significant fibrinous uveitis and the vision was significantly reduced.It was noted that the patient had to go back to the surgical theater.Additional information has been requested.This is one of three medical device reports for this facility.

Manufacturer Narrative

Product evaluation: the device was returned.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger has been retracted and was at mid-nozzle.The device tip was split along the anterior.The device was cleaned for further evaluation.The nozzle was removed.Top coat dye stain testing was conducted with acceptable results.Scrape marks were observed which have caused disruptions to the inner coating.This damage starts prior to the depth guard along the tip anterior.The plunger was removed from the body of the device.No damage was observed to the plunger.The lens was not returned.A qualified viscoelastic was indicated.The specific root cause for the reported events cannot be determined.The nozzle tip of the returned device was split.The interior of the nozzle and tip were scraped, which caused disruptions to the coating.This damage would only occur if the lens and plunger were not in acceptable positions for advancement.Excessive force would have been necessary to cause this type of damage.Top coat dye stain testing was conducted with acceptable results.The directions for use (dfu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome.The statement was made that the environment was warm.The temperature was not provided.The dfu instructs to use the pre-loaded delivery system at operating room temperatures between 18° c (64° f) and 23° c (73° f).If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7337694
• MDR Text Key: 102342668
• Report Number: 1119421-2018-00270
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12561361
• Other Device ID Number: 00380652394840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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
• Treatment: PROVISC OVD
• Patient Outcome(s): Other; Required Intervention