MAUDE Adverse Event Report: COOPERVISION CARRIBEAN CORPORATION AVAIRA TORIC (ENFILCON A)

Lot Number 11274500030003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Eye Injury (1845)

Event Type  Injury  

Manufacturer Narrative

The association between coopervision lenses and the event is unconfirmed.

Event Description

The patient alleges she attended minor injuries and eye casualty, location and contact information unknown, and was treated with antibiotics and a mydriatic for a bacterial infection of the right (od) eye.This information could not be confirmed with medical documentation.The patient was seen post incident by their optician.Per medical documentation received, the optician indicates the patient was left with a corneal opacity within the central 6 mm of the cornea and medical intervention was required to prevent or preclude permanent impairment of eye function or structure due to an infectious corneal ulcer.The optician also indicated that the patient experienced a temporary decrease to vision.As of (b)(6) 2017, the incident has fully resolved with no changes to the patient's visual acuity, the patient has resumed daily wear lens use.

• Brand Name: AVAIRA TORIC (ENFILCON A)
• Type of Device: AVAIRA TORIC (ENFILCON A)
• 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, CA 94588 ; 5857569874
• MDR Report Key: 7108008
• MDR Text Key: 94504567
• Report Number: 2640128-2017-00020
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Lot Number: 11274500030003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• 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: 44 YR