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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION MANUFACTURING LTD AVAIRA SPHERE (ENFILCON A)

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COOPERVISION MANUFACTURING LTD AVAIRA SPHERE (ENFILCON A) Back to Search Results
Lot Number 16739050008016
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Corneal Decompensation (1790); Corneal Ulcer (1796); Headache (1880); Hypopyon (1913); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Visual Impairment (2138); Corneal Infiltrates (2231); Fluid Discharge (2686)
Event Date 11/09/2018
Event Type  Injury  
Manufacturer Narrative
No lenses were returned to the manufacturer for investigation. Lot history, device history, sterilization records and trend reporting were reviewed. No issues or nonconformance's were found and no trends were identified, no root cause could be established. The relationship between the coopervision device and the event is unconfirmed.
 
Event Description
Patient woke with soreness in the right (od) eye on friday (b)(6) and proceeded to use the device, a few hours later experienced redness and discharge upon lens removal. The patient sought medical treatment at an urgent care facility the following day where he was diagnosed with conjunctivitis and prescribed erythromycin ointment. Sunday the patient's symptoms had worsened, and he sought emergency medical treatment and was diagnosed with an 8mm infectious corneal ulcer with the central 5mm raised with underlying infiltrate and 2mm hypopyon. The patient was admitted on (b)(6) and received 24 hours of iv vancomycin and iv ceftazidime, along with oral ciprofloxacin, atropine, and fortified vancomycin drops and fortified ceftazidime drops to be used every hour alternating every 30 minutes initially. The patient was discharged the next day, the vancomycin was discontinued but patient was to continue use with the fortified ceftazidime, atropine, and oral ciprofloxacin. The eye was swabbed, cultures grew positive for pseudomonas. Patient was seen for several follow-up appointments with continued medication and a prokera amniotic graft placed from (b)(6), again (b)(6) and removed as patient was unable to tolerate. As of (b)(6), when last medical information received from the treating physician, the patient is slow to heal but the incident is resolving. The ulcer has decreased in size to 2. 5mm (v) by 4. 0mm (h) with an adjacent smaller epithelial defect and underlying infiltrate and they hypopyon has decreased in size to 0. 25mm consolidating inferiorly. The patient continues to be treated with tobramycin, ciprofloxacin and atropine and is to follow-up in one week. Good faith efforts have been made to obtain additional information without success, additional information is unknown. This event is being reported in an abundance of caution due to unknown resolution.
 
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Brand NameAVAIRA SPHERE (ENFILCON A)
Type of DeviceAVAIRA SPHERE (ENFILCON A)
Manufacturer (Section D)
COOPERVISION MANUFACTURING LTD
south point, hamble unit 2
southampton
hampshire, SO31 4RF
UK SO31 4RF
Manufacturer (Section G)
COOPERVISION MANUFACTURING LTD
south point, hamble unit 2
southampton
hampshire, SO31 4RF
UK SO31 4RF
Manufacturer Contact
melissa torpey
5870 stoneridge drive
suite 1
pleasanton, CA 94588
5857569874
MDR Report Key8202629
MDR Text Key131608958
Report Number9614392-2018-00050
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Lot Number16739050008016
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 Received11/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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