Catalog Number CBV92004051 |
Device Problem
Sharp Edges (4013)
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Patient Problems
Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869)
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Event Date 10/15/2021 |
Event Type
Injury
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Event Description
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A consumer reported, ¿experienced several lenses with a sharp edge, and developed a corneal ulcer¿ after contact lens wear in the right eye.The consumer was treated with antibiotic eye drops and the symptoms resolved.The consumer resumed contact lens wear in the right, and experienced ¿a sharp feeling lens¿ in the right eye and removed the lens.Additional information was requested for this event; however, no updates have been received at this time.
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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.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information updated in a2, b3, b5 h.3., h.6.: the actual complaint product was not returned for evaluation.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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Event Description
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Additional information was received which states that an ulcer occurred on the right medial cornea.Consumer was treated with neomycin, polymyxin b sulfates and dexamethasone ophthalmic suspension from (b)(6) 2021 to (b)(6) 2021.The current status of the consumer eye was recovered.This report of centrally located corneal ulcer, which requires administration of antibiotic eye drops, a serious event, cannot be ruled out at this time of report.
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Search Alerts/Recalls
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