BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM HANDPIECE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
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Model Number BLIS-R1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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The serial number of the handpiece used in the event was not recorded by the account.As a serial number for the device was not provided, the associated device history record was not reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.
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Event Description
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It was reported that after delivery of an intraocular lens (iol) into the eye, the haptic broke off.The iol was removed, the incision was enlarged, a vitrectomy was performed, and sutures were required.The patient was left aphakic and surgery for a replacement iol was planned for a future date.Additional information was requested, but not received.
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Event Description
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Additional information was received indicating an anterior capsular tear occurred prior to insertion of the intraocular lens.
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Manufacturer Narrative
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Based on additional information received, it was determined the device causality is unrelated and therefore, this event no longer meets reportability requirements and is no longer deemed reportable.
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Search Alerts/Recalls
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