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| Lot Number ASKU |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The complaint sample is not available for evaluation; the lot number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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As reported via a literature report entitled, "contact lens-related acanthamoeba keratitis and accompanying dacryoadenitis" (eye & contact lens volume 41, number 4, july 2015), case #1 details the following events: a (b)(6) female patient presented to our clinic with complaints of pain, watering, and stinging in her right eye.From her history, it was learned that she had been using hydrogel toric contact lenses (-3.50 to 1.25 axis 180 diopters [d], base curve: 8.90 mm, diameter: 14.50 mm; vifilcon a, ciba vision) on a daily wear monthly replacement schedule for 6 years, and her care solution was multipurpose contact lens solution (containing polyhexanide %0.0001, sodium phosphate, tromethamine, poloxamer, disodium edta; ciba vision).She had made the following mistakes that might have caused an infection: she had sustained an eye injury with a piece of ice falling from a roof 15 days earlier but continued wearing her lenses, had taken a sauna with her contact lenses on, had slept a few nights with her contact lenses on, and had used her contact lenses without an ophthalmologist¿s examination and contact lens prescription.Her history revealed that a week before presenting to our clinic, the patient received an antiviral (acyclovir ointment)+antibiotic (ofloxacin 0.3% drops) treatment for the above-mentioned complaints, which had not resolved.The eye examination in our clinic showed visual acuity of 3/10 in the right eye, and biomicroscopy revealed eyelid edema, conjunctival hyperemia, limbal infection, stromal edema in the cornea, small central and paracentral infiltrates, very weak infiltration rings around these infiltrates, incision wrinkles, and an increase in the thickness of the cornea.The best corrected visual acuity in the left eye was 10/10 with 23.50 sph (21.0 cyl ax 180°), and all other findings were normal.One week later, the infiltration ring was observed to have become more evident and corneal edema to have increased.For the purpose of diagnosis, corneal swabs were taken and planted on non-nutrient agar enriched with escherichia coli and on the other routine nutrient media; gram-stained and giemsa-stained direct smears were evaluated under light microscopy.Confocal microscopy was conducted.Neither growth on nutrient media nor specific characteristics was observed with light microscopy, but tiny particles with high reflexivity were detected with confocal microscopy.On account of the presence of pain disproportionate to the clinical appearance/manifestation, the formation of immune rings, the lack of response to the (b)(6) treatment, and the results of confocal microscopy, the treatment began with the prediagnosis of ak; the patient was given propamidine isethionate (golden eye drops¿a drop/hr and golden eye ointment¿once a day), neomycin sulfate (neosporin drops¿a drop/hr), and atropine drops 1% (3x1), and itraconazole (itraspor 100 mg capsules¿1x2) taken orally.After a short period of regression lasting 2 weeks, it was observed that corneal abscess had developed quickly in the lower nasal quadrant and that the cornea had become thinner.Fortified tobramycin drops (a drop/hr) and ofloxacin 0.3% (exocin drops¿6x2) were added to the treatment.On her own request, the patient continued her treatment in an eye center abroad.Later, it was learned that at the clinic where the patient was treated, corneal biopsy had been performed, but that 2 days later, urgent keratoplasty with a large greft in the diameter of 9.5 mm had taken place because of corneal perforation, and that postoperatively, a specific antibiotic treatment had been started against the secondary streptococcus pneumonia infection that was detected as a result of biopsy, and dexamethasone sodium phosphate 0.1% 2x1 was added to control postoperative inflammation.Because of increase in the eye pressure, anti-glaucomatous medication was added to the treatment.Two months later, graft rejection occurred, which was treated with tacrolimus (prograf 5 mg capsules¿2x1) and topical cortisone.At posttreatment examination, visual acuity was counting fingers at a distance of 3 m, moderate corneal edema and peripheral anterior sinechia were present, the lens was opaque, and ocular tension was 30 mm hg.A second corneal transplantation was planned in addition to the glaucoma treatment.Based on the cited article, the ecp noted that the acanthamoeba infection may have resulted from ocular trauma (ice falling) and inappropriate contact lens wear (in sauna, sleeping with contact lenses, and using contact lenses without proper contact lens prescription).The ecp cited the herpetic incident is a part of the patient¿s preexisting medical history but did not note it as a factor in the acanthamoeba infection.The stated objective of this report was to discuss the clinical presentation, diagnosis, therapy, and methods for prevention of acanthamoeba keratitis (ak) and to emphasize that inflammatory dacryoadenitis can be seen together with it.The article concluded that, despite the improvements in diagnostic tests and treatment strategies for ak, the role of prevention becomes apparent because of the bad prognosis of this serious complication; thus, contact lens wearers should be aware of the importance of using lenses under ophthalmologist¿s supervision.In addition, it was emphasized that ak may be frequently associated with lacrimal gland inflammation.
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Manufacturer Narrative
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The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.Correction to medical assessment: this diagnosis was supported by the above history, objective findings and non-responsiveness to an initial treatment with anti-herpetic medication.A complex anti-protozoa and antibiotic treatment was prescribed of current pathology and aggressive treatment.(b)(4).
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Event Description
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As reported via a literature report entitled, "contact lens-related acanthamoeba keratitis and accompanying dacryoadenitis" (eye & contact lens volume 41, number 4, july 2015), case #1 details the following events: a (b)(6) female patient presented to our clinic with complaints of pain, watering, and stinging in her right eye.From her history, it was learned that she had been using hydrogel toric contact lenses (-3.50 to 1.25 axis 180 diopters [d], base curve: 8.90 mm, diameter: 14.50 mm; vifilcon a, ciba vision) on a daily wear monthly replacement schedule for 6 years, and her care solution was multipurpose contact lens solution (containing polyhexanide %0.0001, sodium phosphate, tromethamine, poloxamer, disodium edta; ciba vision).She had made the following mistakes that might have caused an infection: she had sustained an eye injury with a piece of ice falling from a roof 15 days earlier but continued wearing her lenses, had taken a sauna with her contact lenses on, had slept a few nights with her contact lenses on, and had used her contact lenses without an ophthalmologist¿s examination and contact lens prescription.Her history revealed that a week before presenting to our clinic, the patient received an antiviral (acyclovir ointment)+antibiotic (ofloxacin 0.3% drops) treatment for the above-mentioned complaints, which had not resolved.The eye examination in our clinic showed visual acuity of 3/10 in the right eye, and biomicroscopy revealed eyelid edema, conjunctival hyperemia, limbal infection, stromal edema in the cornea, small central and paracentral infiltrates, very weak infiltration rings around these infiltrates, incision wrinkles, and an increase in the thickness of the cornea.The best corrected visual acuity in the left eye was 10/10 with 23.50 sph (21.0 cyl ax 180°), and all other findings were normal.One week later, the infiltration ring was observed to have become more evident and corneal edema to have increased.For the purpose of diagnosis, corneal swabs were taken and planted on non-nutrient agar enriched with escherichia coli and on the other routine nutrient media; gram-stained and giemsa-stained direct smears were evaluated under light microscopy.Confocal microscopy was conducted.Neither growth on nutrient media nor specific characteristics was observed with light microscopy, but tiny particles with high reflexivity were detected with confocal microscopy.On account of the presence of pain disproportionate to the clinical appearance/manifestation, the formation of immune rings, the lack of response to the herpes treatment, and the results of confocal microscopy, the treatment began with the prediagnosis of ak; the patient was given propamidine isethionate (golden eye drops¿a drop/hr and golden eye ointment¿once a day), neomycin sulfate (neosporin drops¿a drop/hr), and atropine drops 1% (3x1), and itraconazole (itraspor 100 mg capsules¿1x2) taken orally.After a short period of regression lasting 2 weeks, it was observed that corneal abscess had developed quickly in the lower nasal quadrant and that the cornea had become thinner.Fortified tobramycin drops (a drop/hr) and ofloxacin 0.3% (exocin drops¿6x2) were added to the treatment.On her own request, the patient continued her treatment in an eye center abroad.Later, it was learned that at the clinic where the patient was treated, corneal biopsy had been performed, but that 2 days later, urgent keratoplasty with a large graft in the diameter of 9.5 mm had taken place because of corneal perforation, and that postoperatively, a specific antibiotic treatment had been started against the secondary streptococcus pneumonia infection that was detected as a result of biopsy, and dexamethasone sodium phosphate 0.1% 2x1 was added to control postoperative inflammation.Because of increase in the eye pressure, anti-glaucomatous medication was added to the treatment.Two months later, graft rejection occurred, which was treated with tacrolimus (prograf 5 mg capsules¿2x1) and topical cortisone.At posttreatment examination, visual acuity was counting fingers at a distance of 3 m, moderate corneal edema and peripheral anterior synechia were present, the lens was opaque, and ocular tension was 30 mm hg.A second corneal transplantation was planned in addition to the glaucoma treatment.Information supplied in the initial report: based on the cited article, the ecp noted that the acanthamoeba infection may have resulted from ocular trauma (ice falling) and inappropriate contact lens wear (in sauna, sleeping with contact lenses, and using contact lenses without proper contact lens prescription).The ecp cited the herpetic incident is a part of the patient¿s preexisting medical history but did not note it as a factor in the acanthamoeba infection.The stated objective of this report was to discuss the clinical presentation, diagnosis, therapy, and methods for prevention of acanthamoeba keratitis (ak) and to emphasize that inflammatory dacryoadenitis can be seen together with it.The article concluded that, despite the improvements in diagnostic tests and treatment strategies for ak, the role of prevention becomes apparent because of the bad prognosis of this serious complication; thus, contact lens wearers should be aware of the importance of using lenses under ophthalmologist¿s supervision.In addition, it was emphasized that ak may be frequently associated with lacrimal gland inflammation.Final report: correction to the initial summary conclusion.Omit section,¿ based on the cited article, the ecp noted that the acanthamoeba infection may have resulted from ocular trauma (ice falling) and inappropriate contact lens wear (in sauna, sleeping with contact lenses, and using contact lenses without proper contact lens prescription).The ecp cited the herpetic incident is a part of the patient¿s preexisting medical history but did not note it as a factor in the acanthamoeba infection.The stated objective of this report was to discuss the clinical presentation, diagnosis, therapy, and methods for prevention of acanthamoeba keratitis (ak) and to emphasize that inflammatory dacryoadenitis can be seen together with it.The article concluded that, despite the improvements in diagnostic tests and treatment strategies for ak, the role of prevention becomes apparent because of the bad prognosis of this serious complication; thus, contact lens wearers should be aware of the importance of using lenses under ophthalmologist¿s supervision.In addition, it was emphasized that ak may be frequently associated with lacrimal gland inflammation.¿ replaced section above with the following statement, "a (b)(6) female patient, with history of wearing lenses with no prescription or routine oversight by an ecp, a recent eye injury with a piece of ice and not removing lenses while using a sauna, experienced a corneal ulcer as a result of mixed infection with acanthamoeba and streptococcus pneumonia.This diagnosis was supported by the above history, objective findings and non-responsiveness to an initial treatment with anti-herpetic medication.A complex anti-protozoa and antibiotic treatment was prescribed.The complications of current pathology and aggressive treatment included corneal penetration that was managed with 2 corneal transplants of which 1st one was a reject.The infections and post-operative inflammation were treated with anti-infective and steroid drugs.Increased intraocular pressure and cataract (¿lens was opaque¿) were complications developed post-operatively.This patient was remaining under continuing medical care at the rime of report.Based on these facts, this event is serious and reportable.Note, the date of event occurrence is not specified; the reference article indicates cases described have occurred in the last 15 years." the stated objective of this report was to discuss the clinical presentation, diagnosis, therapy, and methods for prevention of acanthamoeba keratitis (ak) and to emphasize that inflammatory dacryoadenitis can be seen together with it.The article concluded that, despite the improvements in diagnostic tests and treatment strategies for ak, the role of prevention becomes apparent because of the bad prognosis of this serious complication; thus, contact lens wearers should be aware of the importance of using lenses under ophthalmologist¿s supervision.In addition, it was emphasized that ak may be frequently associated with lacrimal gland inflammation.¿.
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