MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. PROCLEAR SPHERE (OMAFILCON B); PROCLEAR SPHERE (OMFILCON B)

Lot Number 15270050023050

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

Patient Problems Cellulitis (1768); Chemosis (1775); Swelling/ Edema (4577)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

No device sample returned for manufacturer analysis.A lot number was provided; 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 incident is unconfirmed.

Event Description

The patient reports that they sought emergency medical treatment for redness and swelling of the eyes and was diagnosed with periorbital cellulitis, conjunctival chemosis, and episcleritis in both eyes (ou).The patient states this was confirmed via a ct scan and was prescribed cephalexin and tobradex.The patient was discharged and advised to follow-up with their eye care provider for follow-up, the patient was scheduled to be seen 8 april.Good faith efforts were made to obtain additional information from the patient on the incident and medical treatment received without success, further information is unknown.This event is being reported in an abundance of caution due lack of medical documentation and the potential severity of periorbital cellulitis.While it is unlikely the device was a cause or contributing factor, the relationship between the device and the event is unknown.

• Brand Name: PROCLEAR SPHERE (OMAFILCON B)
• Type of Device: PROCLEAR SPHERE (OMFILCON B)
• 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: 11791297
• MDR Text Key: 249506127
• Report Number: 9614392-2021-00017
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 15270050023050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/07/2021
• 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
• Patient Age: 53 YR