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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION CARRIBEAN CORPORATION BIOMEDICS 55 UV (OCUFILCON D)

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COOPERVISION CARRIBEAN CORPORATION BIOMEDICS 55 UV (OCUFILCON D) Back to Search Results
Lot Number 12314500021006
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Irritation (1941)
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
The patient alleges she experienced eye irritation, she was diagnosed with an eye infection and prescribed lotemax. Good faith efforts have been made to obtain additional medical information without success, additional information is unknown. This event is being reported due to incomplete diagnosis, lack of medical information, and unknown resolution.
 
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Brand NameBIOMEDICS 55 UV (OCUFILCON D)
Type of DeviceBIOMEDICS 55 UV (OCUFILCON D)
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 Key6999095
MDR Text Key90962714
Report Number2640128-2017-00018
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number12314500021006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/03/2017 Patient Sequence Number: 1
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