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 Problems Chemosis (1775); Endophthalmitis (1835); Hypopyon (1913); Pain (1994); Pneumonia (2011); Sepsis (2067); Swelling (2091); Visual Impairment (2138)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. Additional information has been requested. The manufacturer internal reference number is: (b)(4).

Event Description

An ophthalmologist reported that following an intraocular lens (iol) implant procedure, a patient developed potential endophthalmitis. According to the ophthalmologist, the patient could have had a dormant blood infection while operating. The patient has been admitted the hospital with a blood infection and is on iv antibiotics. Additional information was provided by the ophthalmologist, who reported that the event occurred four days following the initial implant procedure. The patient was seen approximately six hours after the onset of pain, chemosis, some fibrin in the anterior chamber and decreased vision. The patient was referred to the retinal specialist and an aqueous vitreous tap was performed and the patient was injected with intravitreal antibiotics within two hours of the visit. The next day, the patient developed a hypopyon, hand motion vision but less pain. Later developed back pain, went to the er and was admitted with sepsis and a positive blood culture for strep pneumonia. The patient's issues have not resolved. The prognosis is guarded. There was no culture growth at 48 hours. The patient also had vitreous opacity and mild lid swelling.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 8084776
• MDR Text Key: 127592906
• Report Number: 1119421-2018-01622
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2021
• Device Model Number: AU00T0
• Device Lot Number: 12609872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/19/2018 Patient Sequence Number: 1

Treatment

ATROPINE; BALANCED SALT SOLUTION; BETADINE PREP; CENTRION; DUREZOL; LIDOCAINE; OPCEFTAZIDENE; POLYTRIM; RETROBULBAR BLOCK; VANCOMYCIN; VISCOAT