Model Number BL5425WVX |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Endophthalmitis (1835)
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Event Date 08/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device was discarded by the user.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.See related 0001920664-2022-00124 and 0001920664-2022-00125.
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Event Description
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A user facility in japan reported that there were three cases of post-op endophthalmitis on three patients.The third case of endophthalmitis occurred after the balanced salt solution (bss) was changed from a glass bottle product to a soft pack product, and the surgeon thought that the disposable pack may have had some possibility to cause the event.Patients are in remission after being given typical eyedrops, and are no longer under treatment.There was no decreased visual acuity, and no hospitalization was required.This report is on the third case only.
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Manufacturer Narrative
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The product was discarded and is reported as not available.Unable to investigate further for root cause which is unknown.A review of the monthly bioburden results for the six months surrounding the manufacture of this product on 12-10-2021 shows all bioburden values were within acceptable parameters.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.The investigation is complete.See related 0001920664-2022-00124 and 0001920664-2022-00125.
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Search Alerts/Recalls
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