MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. BIOFINITY ENERGYS (COMFILCON A)

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Inflammation (1932); Red Eye(s) (2038); Swelling/ Edema (4577)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

Based on manufacturers investigation no root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

It is reported that the patient was seen with symptoms of redness and swelling.The patient presented with a central extensive inflammatory infiltrate.Around the infiltrate on the epithelium level, numerous cells with halo around with suggest the possible presence of acanthamoeba cysts.Corneal scrapings taken on 15 august for testing, returned positive for pseudomonas aeruginosa.Sample also being tested for acanthamoeba, however, at the time of medical report (dated 20 august) no results returned.Patient was treated with brolene, chlorhexidine, and gentamicin.At follow-up visits patients condition continue to improve.Date of last recorded visit (dated 20 august), patient has a smaller number of inflammatory cells, but numerous halo cells around the infiltrate on the epithelium level remain and continue to suggest the possible presence of acanthamoeba cysts.Outside of the infiltration area, epithelium and proper morphology were seen, no mycelial hyphae (fungus) seen.Patient to be seen in three days for follow-up or seek care if condition worsens.No further medical records provided, patient outcome unknown.Good faith efforts have been made to obtain further information without success.As of the date of report, additional information is unknown.This event is being reported in an abundance of caution due to the confirmation of pseudomonas aeruginosa and potential for acanthamoeba keratitis.

• Brand Name: BIOFINITY ENERGYS (COMFILCON A)
• Type of Device: BIOFINITY ENERGYS (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southamptom, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 12779596
• MDR Text Key: 282122190
• Report Number: 9614392-2021-00027
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P080011
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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; Other
• Patient Age: 16 YR
• Patient Sex: Female