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 inserter 1 of 2.
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The device was not returned for evaluation.A lot number was not provided, so a device history record (dhr) could not be performed for this device.Based on the available 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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