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U.S. Department of Health and Human Services

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

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COOPERVISION CARRIBEAN CORPORATION PROCLEAR TORIC (OMAFILCON B) Back to Search Results
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.
 
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Brand NamePROCLEAR TORIC (OMAFILCON B)
Type of DevicePROCLEAR 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 Key6773152
MDR Text Key82012967
Report Number2640128-2017-00010
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112302
Number of Events Reported1
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
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2018
Device Lot Number10296500021008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2013
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: 08/08/2017 Patient Sequence Number: 1
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