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Lot Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Abrasion (1789); Eye Infections (4466)
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Event Type
Injury
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Manufacturer Narrative
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No product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.It is unknown if the abrasion and infection impacted the right (od) eye, left (os) eye, or both, the device involved in the incident is unknown.As a result, the manufacturer is submitting reports for both the right and left contact lenses potentially involved in the incident, refer to manufacturer reference number (b)(4), manufacturer report number 9614392-2022-00020.
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Event Description
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This incident was reported to the manufacturer by the users purchase location (online retail) via a report from the user.No medical information has been provided by the user, the treating physician(s), or the care facility.The user reports that the contact lenses caused an abrasion in their eye, and they were subsequently diagnosed with an infection.Good faith efforts have been made to obtain additional information without success, as of the date of this report additional information is unknown.This event is being reported in an abundance of caution due to the alleged infection with a lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.
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Search Alerts/Recalls
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