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

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.

• Brand Name: AVAIRA SPHERE (ENFILCON A)
• Type of Device: AVAIRA 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 Key: 8202629
• MDR Text Key: 131608958
• Report Number: 9614392-2018-00050
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133627
• Number of Events Reported: 1
• 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 Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Lot Number: 16739050008016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR