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U.S. Department of Health and Human Services

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

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COOPERVISION, INC PROCLEAR TORIC (OMAFILCON B) Back to Search Results
Lot Number 10431500070024
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Red Eye(s) (2038); Uveitis (2122); Excessive Tear Production (2235)
Event Date 07/16/2020
Event Type  Injury  
Manufacturer Narrative
No lenses returned for analysis. No root cause could be established from investigation, the relationship between the coopervision device and the incident is unconfirmed.
 
Event Description
The incident was initially reported by the patient/user as uveitis with no further details. Additional information received from the patients treating eye care provider. The patient sought medical treatment for symptoms of irritation, redness, photophobia, and watering/discharge of the right (od) eye. The treating eye care provider notes clinical findings of epithelial mild to moderate staining, mild bulbar injection, trace papillae, and trace (5-6) cells. The patient was diagnosed with mild uveitis secondary to contact lens associated red eye and/or dry eye with a history of idiopathic uveitis. The patient was treated with polytrim, prednisolone acetate, and xiidra (lifitegrast) for one week. Patient was seen for follow up at three days with minimal improvement. Patient was prescribed moatropine, maxitrol, and pred forte in addition to previously prescribed medications for one week. Patient was seen for two week follow-up after being seen by uveitis specialist, patient indicates was prescribed durezol and cyclopentalate but no medical records provided for this visit, with improved symptoms. Durezol and cyclopentalate have been discontinued at the advice of the uveitis specialist and all previously prescribed medications from the primary treating eye care provider previously discontinued. Eye care provider notes trace inferior superficial punctate keratitis and no cells, dryness is improving and uveitis has resolved. While patient has a history of idiopathic uveitis, it is the opinion of the treating eye care provider that this incident was associated with the use of contact lenses and medical treatment and/or medication was required to prevent or preclude permanent impairment of the eye function or structure.
 
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Brand NamePROCLEAR TORIC (OMAFILCON B)
Type of DevicePROCLEAR 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 Key10864034
MDR Text Key217077399
Report Number1314956-2020-00002
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
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number10431500070024
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2019
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: 11/18/2020 Patient Sequence Number: 1
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