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Adverse Event Report

CIBA VISION CORP. FRESHLOOK COLORS CONTACT LENS   back to search results
Event Date 12/23/2002
Event Type  Injury   Patient Outcome  Other;
Event Description

An ophthalmologist reported a corneal abscess on the left eye of a pt occurring after a few hours of lens wear. The ophthalmologist stated that it was probably freshlook colors but could not confirm this. The eye was very red, watery and visual acuity reported as 4/10. The ophthalmologist prescribed eye drops, ointment & local antibiotic treatment. The ophthalmologist stated that the incident was the result of poor lens hygiene. No further info is available at this time.

 
Manufacturer Narrative

The report was reviewed by cv medical review committee with the following conclusion: "corneal abscess of unk etiology occurring after several hours of wear of the lens. Poor hygiene suspected. Treated with antibiotic. Final outcome unk, but last reported aculty was 4/10". As there was no product or lot number provided, no detailed investigation can be performed. We will continue to monitor and trend this type complaint.

 
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Brand NameFRESHLOOK COLORS
Type of DeviceCONTACT LENS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CIBA VISION CORP.
333 east howard ave.
des plaines IL 60018
Manufacturer (Section D)
CIBA VISION CORP.
333 east howard ave.
des plaines IL 60018
Manufacturer Contact
pat strahl
11460 johns creek parkway
duluth , GA 30097
(678) 415 -3816
Device Event Key439201
MDR Report Key450202
Event Key426338
Report Number1422160-2003-00003
Device Sequence Number1
Product CodeLPL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/28/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/26/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE PROVIDED.,

Database last updated on February 28, 2009

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