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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR Back to Search Results
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.
 
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Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Type of DeviceLENS, 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 Key8084776
MDR Text Key127592906
Report Number1119421-2018-01622
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
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 Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Model NumberAU00T0
Device Lot Number12609872
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 Received12/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2018
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
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