Model Number 60081L |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 08/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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According to the reporter, the product is not available for evaluation.The investigation is ongoing.
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Event Description
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Case 2 of 10.It was reported that the viscoelastic hub had blown after it was screwed into the cannula.This was noticed the second time the viscoelastic was used during surgery while dispensing to insert the intraocular lens (iol).The viscoelastic was removed and replaced once it was noticed.The reporter indicated that nine similar incidents had occurred at the facility over the last three months.The account indicated the safety guide that was recently added to the product is not used and never will due to time constraints.
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Manufacturer Narrative
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The investigation is ongoing.
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Event Description
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Case 2 of 10.It was reported that during the use of the viscoelastic, there was patient contact, but no injuries were sustained from the broken viscoelastic hub/vial.There were no sutures used.
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Manufacturer Narrative
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Additional information- g4, h10/11.A batch record review of the lot was performed.There were no deviations or comments within the manufacturing batch record that would result in the observed complaints.Final product testing for viscosity and extrusion force are within specification.No similar events have been reported for this product lot to date.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.No root cause related to the manufacturing process could be identified.No corrective action is necessary at this time.
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Search Alerts/Recalls
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