MAUDE Adverse Event Report: COOPERVISION, INC. PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Eye Injury (1845); Irritation (1941); Encephalitis (2429)

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

It was reported that in (b)(6) of 2016 the patient experienced eye irritation and was hospitalized for a bacterial infection and encephalitis while using the product.The patient has since resumed lens use with the same product.Good faith efforts have been made to obtain additional information without success, additional information is unknown.This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unclear resolution.

• Brand Name: PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
• Type of Device: PROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
• Manufacturer (Section D): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer (Section G): COOPERVISION, INC.; 711 north road; scottsville NY 14546
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 7417602
• MDR Text Key: 105110348
• Report Number: 1314956-2018-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 03/13/2018
• 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): Hospitalization; Other