Catalog Number CBV92000509 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Ulcer (1796); Red Eye(s) (2038); Excessive Tear Production (2235); Discomfort (2330)
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Event Date 12/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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The complaint sample has not returned for evaluation.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.This is the second of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to the first report filed under the manufacturer internal reference number of (b)(4) for the reported lot number 31380990.The manufacturer internal reference number is: (b)(4).
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Event Description
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As initially reported by a health care professional, a consumer had been experiencing discomfort, red eye and tearing in the left eye (os) which resolved with removal of the contact lenses.The consumer visited the ophthalmologist and was diagnosed with a corneal ulcer in the os.The use of contact lenses was suspended for three months and consumer recovered from ulcer on (b)(6) 2021.The consumer resumed contact lens wear and experienced a new "lesion" in the os, which was treated with a combination of gatifloxacin 0.3% one drop a day for fifteen days and dexamethasone 0.1% for ten days.The current status of the consumer¿s eye is recovered.Additional information has been requested, but not yet received.
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Event Description
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Additional information was received indicating that the that the corneal ulcer occurred in the left eye respective to the product associated with this event.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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