Catalog Number CBVUNK00007 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Abrasion (1789); Intraocular Infection (1933); Visual Impairment (2138)
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Event Type
Injury
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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As initially reported by a female consumer via email on (b)(6) 2021 and the follow up information received on 06aug2021.It was stated that on an unknown date, the consumer experienced severe corneal infection with these lenses.On (b)(6) 2021, the consumer sought medical attention and was diagnosed with cornea scratch.On an unspecified date, the culture test was performed and the result showed bacterial infection.It was also stated that the infection caused decrease in visual acuity by 2 snellen lines.The consumer was prescribed with drops and lubricants as s treatment.Symptom resolution was unknown.Additional information has been requested but not yet received.
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Manufacturer Narrative
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B5., d9., h3.; new information has been received and the additional information has been updated.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received on 24-sep-2021.The symptoms were resolved.
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Search Alerts/Recalls
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