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U.S. Department of Health and Human Services

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

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COOPERVISION, INC. PROCLEAR MULTIFOCAL TORIC (OMAFILCON B) Back to Search Results
Lot Number CV4306908P
Device Problems Detachment Of Device Component (1104); Torn Material (3024)
Patient Problems Abrasion (1689); Bacterial Infection (1735); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Analysis cannot be performed. No lenses were returned for evaluation. The association between coopervision lenses and the event is unconfirmed.
 
Event Description
Patient reported a contact lens tore while in the eye and was unable to remove a piece. The patient was seen for lens removal and indicates the lens caused two abrasions that were treated with antibiotics. The patient later was diagnosed with a (b)(6) infection that was treated with (b)(6). While a (b)(6) is not normally caused by lens wear, and would not be a reportable incident, in this instance, it is likely the trauma from the alleged damaged lens and resulting eye injury likely caused or contributed to the infection. Good faith efforts have been made to obtain additional information regarding the injury, medical treatment provided, and outcome. This incident is being reported in an abundance of caution due to the potential relationship with lens use, lack of medical information, and unknown outcome.
 
Manufacturer Narrative
Analysis cannot be performed. No lenses were returned for evaluation. The association between coopervision lenses and the event is unconfirmed.
 
Event Description
Received additional medical information from the treating eye care provider. Patient was experiencing a foreign body sensation and eye pain of the right (od) eye; a torn lens was removed from the conjunctival sac and patient was diagnosed with a corneal abrasion with no evidence of infection or dehiscence. Patient was prescribed ocuflox. At follow-up on patient was diagnosed with anterior uveitis, patient instructed to continue use with ocuflox and was prescribed zirgan and acyclovir. At follow-up patient was diagnosed with herpes simplex in the right (od) eye. At the next three follow up visits, it was documented patient's symptoms continued to improve. As of (b)(6) 2017 eye care provider indicates the incident has fully resolved.
 
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Brand NamePROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
Type of DevicePROCLEAR 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 Key6367653
MDR Text Key68609915
Report Number1314956-2017-00003
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Lot NumberCV4306908P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/01/2017 Patient Sequence Number: 1
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