MAUDE Adverse Event Report: COOPERVISION MANUFACTURING LTD. PROCLEAR 1 DAY (OMAFILCON A)

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

Patient Problems Corneal Ulcer (1796); Pain (1994)

Event Date 11/28/2017

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

The patient experienced pain in the right (od) eye and sought medical treatment.The patient was diagnosed with a corneal ulcer, location and severity unknown, and was prescribed cravit ophthalmic solution, tobracin ophthalmic solution, and ecolicin ophthalmic ointment.The patient was seen one week later for follow-up and the pain had resolved, it is unknown if the incident resolved.Good faith efforts have been made to obtain additional medical information without success, additional information is unknown.This event is being reported due to lack of medical information, and unknown resolution.

Event Description

The patient experienced pain in the right (od) eye and sought medical treatment.The patient was diagnosed with a temporal paracentral corneal ulcer.The patient was seen one week later for follow-up and the pain had resolved.As of (b)(6) 2018, the incident has fully resolved and the patient has resumed lens use.

• Brand Name: PROCLEAR 1 DAY (OMAFILCON A)
• Type of Device: PROCLEAR 1 DAY (OMAFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING LTD.; chandlers ford, erith house; warrior close; eastleigh, hampshire SO53 4TE; UK SO53 4TE
• Manufacturer (Section G): COOPERVISION MANUFACTURING LTD.; chandler for, erith house; warrior close; eastleigh, hampshire, SO53 4TE; UK SO53 4TE
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 7151107
• MDR Text Key: 95935173
• Report Number: 3003981983-2017-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 36 YR