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Adverse Event Report

CIBA VISION CORP. FOCUS DAILIES ONE-DAY DAILY WEAR SOFT CONTACT LENS   back to search results
Lot Number 2092234
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/28/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Customer suffered an infectious corneal ulcer in their right eye associated with focus dailies. They had first experienced mild pain when removing their lens on 28th january 2003. The pain worsen overnight and she visited a dr (date unspecified. ) 4 days later they were hospitalized. The primary diagnosis made by the hospital was suppurative keratitis due to a 5mm x 5mm corneal ulcer and 8mm x 8mm abscess in the pt's right eye. Pseudomonas aeruginosa was detected and intensive antibiotic therapy (gentamicin, cephalexin, tobramycin) was initiated followed by slow introduction of tipocal steroids, and oral-prednisolone. The pt has an amniotic membrane graft. A follow-up examination re-epithelialisation was reported and the topical steroid therapy was increased. The pt was discharged from hosp with continuing antibiotic (topical gentamicin and tobramycin and oral doxycycline. ) and (steroidal dexamethasone and hydrocortisone therapy. ) they attended the hosp outpatient department for follow-up appointments. No details of the outcome of these examinations are supplied. Add'l info has been requested. No further info is available at this time.

 
Manufacturer Narrative

The report was reviewed by the ciba vision medical review committee with the following conclusion: "culture-positive infectious ulcer (pseudomonas aeruginosa. ) this was diagnosed as a large abscess, with a 5mm ulcer. The pt was hospitalized and received intensive antibiotic therapy, followed by topical and oral steroids, and an amniotic membrane graft. It is not known if there was any permanent damage to the eye as there is no report of the final state of the cornea or best-corrected visual acuity. " h4 & h6: the device history records and sterility records are under review by mfg. If records are found to be out of compliance, a follow up report will be provided.

 
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Brand NameFOCUS DAILIES ONE-DAY
Type of DeviceDAILY WEAR SOFT CONTACT LENS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CIBA VISION CORP.
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section D)
CIBA VISION CORP.
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
CIBA VISION CORP.
11460 johns creek parkway
duluth GA 30097
Manufacturer Contact
pat strahl
11460 johns creek parkway
duluth , GA 30097
(678) 415 -3816
Device Event Key462400
MDR Report Key473552
Event Key448853
Report Number1065835-2003-00001
Device Sequence Number1
Product CodeLPL
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT Number2092234
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/03/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/24/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE REPORTED.,

Database last updated on December 31, 2008

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