MAUDE Adverse Event Report: COOPERVISION CARRIBEAN CORPORATION PROCLEAR TORIC (OMAFILCON B)

Lot Number 10296500021008

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problems Corneal Abrasion (1789); Keratitis (1944); No Code Available (3191)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The association between coopervision lenses and the event is unconfirmed.

Event Description

The patient reports that a contact lens tore while in the left (os) eye and could not be removed.The patient alleges she was seen for lens removal and the incident resulted in a corneal abrasion.The eye care provider states the patient was seen on (b)(6) but there was no foreign body in the eye.The patient had a mild excavated epithelial defect and mild conjunctival injection.The eye care provider diagnosed microbial keratitis and prescribed vigamox ophthalmic solution one drop every three hours.Patient was to return for follow up in three days but cancelled the appointment and did not seek any further follow up care.This event is being reported due to the nature of the diagnosis (microbial keratitis) and unknown resolution.

• Brand Name: PROCLEAR TORIC (OMAFILCON B)
• Type of Device: PROCLEAR TORIC (OMAFILCON B)
• Manufacturer (Section D): COOPERVISION CARRIBEAN CORPORATION; 500 road 584; lot 7; amuelas industrial park, juana diaz 00795
• Manufacturer (Section G): COOPERVISION CARRIBEAN CORPORATION; 500 road 584; lot 7; amuelas industrial park, juana diaz 00795
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton 94588 ; 5857569874
• MDR Report Key: 6773152
• MDR Text Key: 82012967
• Report Number: 2640128-2017-00010
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/08/2017

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 Expiration Date: 10/01/2018
• Device Lot Number: 10296500021008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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: 33 YR