MAUDE Adverse Event Report: COOPERVISION CARIBBEAN CORPORATION ENFILCON A / AVAIRA SPHERE

Lot Number 491355004610

Device Problems Difficult to Remove (1528); Sticking (1597); Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problems Corneal Abrasion (1789); Edema (1820); Erythema (1840); Irritation (1941); Pain (1994)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Coopervision received information on 8/30/2014 from a patient who related that with a new box of contacts, every pair worn within 2 days or less would cause red and irritated eyes.These were noted to be torn upon removal.In (b)(6) 2014, the patient pulled one of the contacts out of her left eye with two fingers because it was stuck and upon doing so became irritated and later that evening painful.The patient saw an eye care practitioner (ecp) on the next day who noted a scratched cornea, ordered maxitrol eye drops and every few days follow up.On (b)(6) 2014, coopervision received a medical report regarding five ecp visits from (b)(6) 2014.The initial visit medical history relates that the patient complained of pain and light sensitivity in the left eye with onset the night before ((b)(6) 2014) caused by difficulty removing left lens.Vision was od 20/20 and os 20/25 with glasses.Slit lamp showed corneal abrasion in left eye with trace cells.The right eye was clear.The patient was prescribed maxitrol and in a later visits lotemax for corneal edema.The details of this first visit ((b)(4) 2014) were recorded in the graphic details section of the medical report of ((b)(6) 2014) as history which related mild epithelial staining and edema, trace stromal edema, trace limbal and bulbar injection and trace supra-central corneal abrasion.There was a temporary decrease in left eye visual acuity, a peripheral scar or opacity, and corneal abrasion.The final outcome of (b)(6) 2014 visit relates medications were discontinued, the condition was resolved and contact lens wear resumed and left eye vision 20/20 with glasses.The ecp indicated that there were no permanent medical conditions, but did indicate that medical intervention was required to preclude permanent impairment of eye function or structure for a persistent epithelial defect.Therefore, this is being reported due to the medical intervention.No lenses were returned.

Manufacturer Narrative

The subject lens was not returned for inspection.The complaint is unconfirmed.The association between coopervision lenses and the incident is unconfirmed.

• Brand Name: ENFILCON A / AVAIRA SPHERE
• Type of Device: ENFILCON A / AVAIRA SPHERE
• Manufacturer (Section D): COOPERVISION CARIBBEAN CORPORATION; 500 road 584; amuelas industrial park; juana diaz PR 00795
• Manufacturer (Section G): COOPERVISION CARIBBEAN CORPORATION; 500 road 584; amuelas industrial park; juana diaz PR 00795
• Manufacturer Contact: joe nesci ; 6150 stoneridge mall road; suite 370; pleasanton, CA 94588-3176 ; 9256273775
• MDR Report Key: 4122402
• MDR Text Key: 20786524
• Report Number: 2640128-2014-00011
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2017
• Device Lot Number: 491355004610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 49 YR