Model Number BL1UT2400125 |
Device Problems
Device Markings/Labelling Problem (2911); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this complaint is in progress.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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It was reported that two toric lenses that were prepared for surgery did not have axis markers on them.This problem was discovered after the surgeon had made an incision into the patient's eye.As a result of the missing axis markers, the surgery was canceled.This mdr is for lens 1 of 2.
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Manufacturer Narrative
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Investigation of this complaint is in progress.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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Additional information was received and clarified that no issues with the lens axis markers were in fact observed.Instead, it was reported that the haptics of a toric lens sheared off during implantation, resulting in the lens having to be removed from the eye.A second toric lens was then attempted for implantation, but the haptics once again sheared off.This lens also had to be removed from the eye.No incision enlargement or sutures were necessary during the surgery, but the patient was left aphakic at the end of the procedure.The patient then returned four days later and had a different model lens successfully implanted with no issues.This mdr is for lens 1 of 2.
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Manufacturer Narrative
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The lens was returned for evaluation.Visual inspection found the lens torn in pieces.The optic is complete and has the haptics from one side attached.The haptics from the other side are torn off.The cause of the damage cannot be determined.Functional testing cannot be performed due to the damage.A device history record (dhr) review was performed and did not find any nonconformities or anomalies related to this complaint.Based on the current information, the exact root cause could not be conclusively determined.However, it is likely that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.
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Search Alerts/Recalls
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