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Adverse Event Report

ALLERGAN PHARMACEUTICALS (IRELAND) LTD. COMPLETE UPGRADE B CONTACT LENS CARE PRODUCT   back to search results
Device Problem Unknown (for use when the device problem is not known)
Event Date 08/22/2002
Event Type  Injury   Patient Outcome  Hospitalization;
Event Description

A pt had been using complete reported that they woke up early in the morning presenting with a swollen eye, od, which made necessary a visit at an ophthalmologist. Family member continued that the cornea was injured and drugs were prescribed but as the state of health worsened they brought the pt to a hospital where they were hospitalized for 1 week. According to the family member, the hospital report stated that the injury has been caused by a germ which was in the contact lens care solution (the contact lenses, solution and the lens case were examined). The pt was discharged from hospital with a persistent corneal scar and a worsening of the visual acuity from -3 to -4 in right eye and from -3 to -3. 5 in left eye. They had to buy new glasses and need to buy new contact lenses as the patient is a competitive athlete (apparatus gymnastics). The hospital report states the following: hospitalization in 7 days diagnosis: corneal ulcer, ou: myopia. Hospitalization findings: visus od: cc. 0. 2, os: cc. 0. 8. Tensio cu: palpatory normotonic. Anterior sector od: conjunctiva: injected, parcentral below oval corneal ulcer with endothelial films, fibrin-memnbrane. Pupil: rounded, clear. Lens: clear. Fundus od shadowy view, homogenious fundic red. Anterior sector os: according to age regular. Fundus cs: papilla vital, sharp margin, within niveau, macula intact, periphery unremarkable, retina circular tight-fitting. A conjunctival swab showed pseudomonas aeruginosa cd. In the lens care solution they found serratia marcescens and gram-negative rods. Discharge findings: cd: visus: cc. Spt. 0,4. Cornea nearly clear, small round healing ulcus, epithelium closed. Anterior chamber: deep, empty. Lens: clear. Papilla vital, sharp margin, within niveau, physiological excavated, macula intact, with reflex, periphery unremarkable, retina circular tight-fitting. Discharge therapy: 4 x dexamytrex ointment, 4 x floxal eyedrops, 1 x mydrum eyedrops qhs. Conclusion and assessment: under intensive corneal caring and antibiotic therapy with floxal ointment qid, dexamytrex ointment qid (after closer of epithelium), the corneal ulcer presented nearly completely healed on the day of the discharge. The hospital spoke in detail with the patient about a possible renewed fitting of contact lenses in about 2-3 months. They emphasized to optimate the contact lens cleaning. On 7 january 2003 received information from the eye doctor who treated the patient after they were discharged from hospital: after recovery of the ulcer a corneal scar remained which decreases the visual acuity in the right eye. As the patient does a lot of sports it was very hard for them not being able to practice it as they were not allowed to wear contact lenses. At the moment it is planned that the patient tries to wear lenses during sports. The sponsor was unable to obtain the complaint unit, lenses and lens case for evaluation purposes. Retain testing not possible as lot number is unknown. No further information is available or expected. Corrective treatment: 4 x dexamytrex ointment, 4 x floxal eyedrops, 1 x mydrum eyedrops qhs.

 
Manufacturer Narrative

The mfr was unable to obtain the complaint unit and lenscase for eval purposes; lot number information is not available to perform eval of retained units. No conclusion can be drawn.

 
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Brand NameCOMPLETE UPGRADE B
Type of DeviceCONTACT LENS CARE PRODUCT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLERGAN PHARMACEUTICALS (IRELAND) LTD.
carrowbeg, castlebar road
westport, county mayo
IRELAND
Manufacturer (Section D)
ALLERGAN PHARMACEUTICALS (IRELAND) LTD.
carrowbeg, castlebar road
westport, county mayo
IRELAND
Manufacturer Contact
paul nowacki
1700 east saint andrews place
santa ana , CA 92799
(714) 247 -8601
Device Event Key428495
MDR Report Key439556
Event Key416022
Report Number2020664-2002-00012
Device Sequence Number1
Product CodeLPN
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Other
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 10/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/07/2002
Was Device Evaluated By Manufacturer? No
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: 01/22/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,BRAND NAME 1: COMPLETE LENS CASE, DEVICE TYPE:,
2,CONTACT LENSES.,

Database last updated on January 30, 2009

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