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

Lot Number 491350936910

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Keratitis (1944); Pain (1994); Eye Burn (2523)

Event Date 12/23/2014

Event Type  Injury  

Event Description

Coopervision was informed on (b)(6) 2015 that on (b)(6) 2014, a (b)(6), female patient removed their contact lenses due to severe pain immediately after insertion.The patient did not wear lenses until improved for one week after the initial event.New contact lenses from same package were inserted on (b)(6) 2015 and within 3 hours of wear eyes were reported as bright red.Contacts were removed but pain continued.Patient was seen by eye care practitioner (ecp) on (b)(6) 2015.Patient described a diagnosis of severe keratitis and severe corneal burns.Three weeks after visit, patient was still in treatment for corneal burns and had been treated with antibiotics and steroids to help healing.Patient alleges that both the patient and ecp believe the contact lenses were "tainted" either in the solution or material used.The patient reported the event to the fda.Ecp was contacted for follow up.Ecp relates six visits.Patient initial complaint was that on (b)(6) 2015 patient inserted fresh lenses and had redness and burning within 4 hours and then removed lenses.Exam revealed severe epithelial staining and edema both eyes, moderate limbal and bulbar injection both eyes.The patient was treated with antibiotics and steroids.The ecp diagnosed superficial keratitis.Contact lens wear was permanently discontinued on (b)(6) 2015.It is unknown if event resulted in permanent injury or that the medical intervention received was to preclude permanent injury.There was a temporary decrease in visual acuity both eyes.Patient 2-week follow up exam related spk in both eyes.Comfort and vision improved.Lotemax tapered as directed until it was gone.Patient wears glasses for distance.Using artificial tears 3-4 times daily in both eyes.No lenses were returned for inspection.The lot number was provided.The compliant is unconfirmed.A request for lens return was denied by the patient because according to the patient, she was advised against doing that as it is evidence.

Manufacturer Narrative

The subject lens was not returned for inspection.The complaint is unconfirmed.The association between coopervision lenses and the incident is uncomfirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative that medical personnel caused or contributed to the event and/or the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged event.Patient refused to return device.

Manufacturer Narrative

Cvi received additional information from the patient's ecp, which states that the complaint fully resolved on 06/15/15, patient's current va is od: 20/25 & os: 20/20, patient diagnosed with a chemical corneal injury, and ofloxacin, erythromycin and lotemax were prescribed.

• 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: 4601463
• MDR Text Key: 5629019
• Report Number: 2640128-2015-00004
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2018
• Device Lot Number: 491350936910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/13/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR