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Model Number 15980 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Eye Burn (2523)
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Event Date 03/17/2023 |
Event Type
Injury
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Event Description
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Iridex became aware of a patient experiencing scleral coagulation during treatment with the g-probe.The doctor reported that the tip of the probe was different and may have resulted in this incident.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
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Event Description
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Part a is not filled out as patient identifier details were not provide to iridex.This report has been created to make corrections to the previous report.The changes include: 1) report c: is this a combination product - no.2) report d: updates to section d8, d9.3) part h: update to include that this a correction report.4) part d: update the lot number information.The lot number was filled out in the section for serial number.Updated this section with the udi number.5) part e: updates to the initial reporter section with information regarding the complainant.6) part h4: updates to date of manufacture.This information was not submitted previously.The following text were provided in the initial report: iridex became aware of a patient experiencing scleral coagulation during treatment with the g-probe.The doctor reported that the tip of the probe was different and may have resulted in this incident.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.
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Search Alerts/Recalls
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