Model Number BL2330 |
Device Problem
Increase in Pressure (1491)
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Patient Problems
Eye Injury (1845); Capsular Bag Tear (2639)
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Event Date 05/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
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Event Description
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The user facility initially reported too much power through hand piece that caused torn capsule in the eye.Additional information from the surgeon: the doctor reported an irrigation aspiration issue.Patient underwent a mechanical vitrectomy, the posterior iol was removed, and an anterior lens implanted.Five day post-op the patient's vision is improving; however the doctor referred the patient to a retina specialist.
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Manufacturer Narrative
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Field service was on site and found the iop port was loose.The iop port assembly was replaced.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.
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Manufacturer Narrative
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The module was tested and verified the phaco output by running the phaco function for 30 seconds at 50% 50 times and at 100% power 50 times.We monitored the power output for a spike exceeding the maximum acceptance specification of 21 watts and 42 watts.The power output stayed consistently at an average of 18 watts at 50% and 35 watts at 100%.The average was consistent with anterior modules tested at the service depot.Usm06770 has no complaint or repair history with the service department.The device history was reviewed and found to meet manufacturing specification.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
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Event Description
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Additional information: the doctor reported an irrigation aspiration issue.The sales rep worked with the doctor and believes the issue is with a lose iop port.
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Search Alerts/Recalls
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