Model Number SY60WF |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Uveitis (2122); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified the manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that following implantation of an intraocular lens (iol) the patient suspected to have allergic symptom appeared and patient was allergic to acrylic lenses.Fibrin continues to appear and is controlled with steroid eye drops, no edema.Patient hard to see, burred vision.In order to eliminate the possibility of the cause, in considering a possibility of allergies, first of all, he is thinking of performing a patch test at a dermatologist, which is less invasion for the patient.Additional information was requested and received.There are two medical device reports associated with this patient.This report is associated with the left eye.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was requested and received patient had been on steroid eye drops for one month postoperatively at his previous physician, during this period the patient was well with no onset of symptoms.After the steroids were cut off a month later, fever, nausea, and cells began to develop, fibrin deposition.The patient is currently in the hospital for a patch test and other tests.There are two medical device reports associated with this patient.This report is associated with the left eye.
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Event Description
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Additional information was requested and received stating patient experienced allergic symptoms such as eye inflammation, fever, and nausea.Additional information was received stating patient had been flare values are not as high as they used to be and are decreased, but they are still continually showing up (60 to about 20).Patient complained of blurred vision and some vitreous opacity due to inflammation.The patient was discharged from the hospital after a patch test of all intraocular lenses, including suspect and other companies' lenses, was conducted to confirm allergy.Physician commented that he did not know the cause.There is no infection.Additionally it was reported that patient was under observation and the anti-bacterial agent has been changed.The flare value was also decreased slightly.However, the specific values could not be confirmed with the doctor.The patient stated that he feels a little better.
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Manufacturer Narrative
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Additional information was provided in b.5.And h.6.The manufacturer internal reference number is:(b)(4).
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Event Description
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Additional information received stating that the patient was coming to the clinic every 3 weeks to 1 month for follow-up.The flare value has been decreasing a little.The patient was no longer concerned about it and symptoms have settled down.Additionally it was mentioned that, it seems that the lens was not the cause of the symptoms.
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Manufacturer Narrative
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Additional information was provided in b.5.And b.6.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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