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Lot Number 12252070061503 |
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); Eye Infections (4466); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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This incident was reported by the end user's location of purchase to the manufacturer.It was reported that the patient experienced symptoms of swelling of the lower eyelid, runny eyes and redness and sought medical treatment.It was reported that the patient experienced a corneal ulcer and/or infection event and unspecified antibiotic medication(s) were prescribed.Good faith efforts have been made to obtain further information without success.As of the date of report, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown patient outcome.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.As patient was using a different device/model in each eye and it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report cc553129 9614392-2024-00014 for additional device incident report.
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Manufacturer Narrative
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No device sample was returned for manufacturer analysis.A lot number was provided for the device alleged to be involved in the incident.Lot history, device history, sterilization records, and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.Should additional information become available, coopervision will complete additional investigations and submit a follow-up report as appropriate.As patient was using a different device/model in each eye and it is unknown which eye (os/od) , or if both eyes (ou) were involved, please refer to linked manufacturer report cc553129 9614392-2024-00014 for additional device incident report.
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Search Alerts/Recalls
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