MAUDE Adverse Event Report: COOPERVISION MANUFACTURING LTD CLARITI ELITE FRP (SOMOFILCON A)

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Conjunctivitis (1784); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Visual Impairment (2138); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed.No lenses were returned for evaluation and lot number is unknown.The association between coopervision lenses and the event is unconfirmed.

Event Description

Medical information received from (b)(6), registered medical practitioner and medico-legal worker.Information received is mr.(b)(6) interpretation of information from the patient (interview and post-resolution exam) and the patient's medical records, medical records have not been received by the manufacturer for review.The patient initially presented with pain and swelling in the right eye and sought medical treatment.The patient underwent treatment beginning (b)(6) 2017 with last available medical records dated (b)(6) 2017, additionally a medical exam was completed by mr.(b)(6) on (b)(6) 2018.During that time, the patient was treated by her gp at the clinic, (b)(6), and at (b)(6) hospital, with primary treatment at the department of ophthalmology at ayr hospital.Over the period of july to september the patient experienced symptoms of eye pain, reduced vision, redness, swelling of the upper and lower right eyelid, and photophobia.The patient experienced conditions of reduced vision, viral kerato-conjunctivitis, contact lens related keratitis (inflammation), and was diagnosed with peri-orbital cellulitis, candida fungal infection, and acanthamoeba keratitis infection.Cultures were taken from the patient's eye, used contact lens storage case, along with the solution and contact lenses which were stored in the case.The presence of candida fungus and acanthamoeba amoeba was confirmed in the solution from the lens storage case.Both of these positive cultures were obtained from a source which have been exposed to environmental contaminants.Results of cultures directly from the eye were not disclosed.There is no indication that the original solution bottle was cultured.The patient was prescribed several medications during treatment; clarithromycin, exocin (ofloxacin), acyclovir tablets, acyclovir eye ointment, fluorometholone, celluvisc, natamycin, chlorhexidine, preservative free chloramphenicol, fluconazole tablets, preservative free dexamethasone.On (b)(6) the patient felt her vision had returned to normal and she was symptom free.Upon exam by mr.(b)(6) in (b)(6) 2018 the incident was fully resolved and best corrected vision was 6/5.

• Brand Name: CLARITI ELITE FRP (SOMOFILCON A)
• Type of Device: CLARITI ELITE FRP (SOMOFILCON 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: 7606737
• MDR Text Key: 111262703
• Report Number: 9614392-2018-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• 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): Other; Required Intervention
• Patient Age: 17 YR