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

Model Number AU00T0

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Visual Impairment (2138); Discomfort (2330); Discomfort (2330)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, the proximal haptic entered the eye inversely complicating the correct position inside the capsular bag.The postoperative refractive result presented an error of one diopter spherical power.In a follow up, the surgeon reported the iol was inserted wrong into the patient's eye, and when he turned the lens it caused profuse bleeding.When the iol was apparently positioned, the surgeon left the lens implanted.The surgeon plans to use viscoelastic to turn the iol over and place it in the capsular bag.The surgeon reported if this cannot be done, he will remove the iol and replace it with another lens model.The surgeon reported the patient experienced discomfort due to anisometropia.The target refraction was -0.75, but the patient was -3.00 postoperatively.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon reported in a follow up that the iol is still implanted in the patient's eye, but the patient may have zonular dialysis.The surgeon reported a vitrectomy may be necessary during a second procedure.The patient also has an astigmatism that does not coincide with the cornea, and has many aberrations.

Manufacturer Narrative

This supplement is being filed to correct the value to adverse event and product problem.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: 7655130
• MDR Text Key: 112891771
• Report Number: 1119421-2018-00843
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: AU00T0
• Device Lot Number: 12527450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 10/29/2018
• Supplement Dates FDA Received: 07/31/2018; 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Other