Lot Number 31132431 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Corneal Ulcer (1796)
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Event Type
Injury
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Manufacturer Narrative
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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 additional report submitted under manufacturer internal reference (b)(4).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.(b)(4).
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Event Description
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As initially reported by an optician, a consumer developed a corneal ulcer associated with contact lens wear.The consumer, having worn the same product for many years, reported that the contact lens felt different in comparison to previous ones worn.Additional information has been requested but not yet received.
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Manufacturer Narrative
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An unknown sample was returned for evaluation and was consistent with the reported lot 31132431.This sample was found to meet manufacturing specifications.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.
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Event Description
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Additional information was received on 10/14/2017 stating that the consumer has tried another lens after the incident and the corneal ulcer reoccurred.The optician thought that the problem may be with the consumer's eye and not with the lens.Additional information has been requested but not yet received.
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Search Alerts/Recalls
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