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Model Number SCP680300 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Keratitis (1944); Eye Burn (2523)
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Event Type
Injury
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Manufacturer Narrative
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Initial reporter telephone number: (b)(6).A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for the compact intuitiv system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, no response has been received.
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Event Description
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A hospital reported a cataract patient experienced damage to the endothelium as a result of a corneal burn with the use of a compact intutiv system and ellips fx phaco handpiece.Although, the cataract procedure was completed and the lens was implanted in the capsular bag, it was reported surgical intervention was required.In addition, the injury to the damage endothelium may have caused keratitis.Attempts were made to obtain additional information; however, no further information is provided.This report is for the compact intutiv system.A separate report will be submitted for the ellips fx phaco handpiece.
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Search Alerts/Recalls
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