Model Number 85915ST |
Device Problems
Product Quality Problem (1506); Defective Component (2292)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 10/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product has not been received for evaluation.Review of manufacturing and sterilization records, trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.
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Event Description
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A user facility in the united kingdom reported that during surgery the sleeve is collapsing and sticking the inner aspiration tube at the corneal incision site.There was a sudden advancement and a posterior capsule rupture occurred during irrigation and aspiration.The procedure was changed and a vitrectomy was performed on the patients eye.Surgery was increased 15-30 minutes.
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Manufacturer Narrative
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Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is ongoing.
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Manufacturer Narrative
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Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.Product was evaluated and confirmed the findings, the sleeve is flimsy and thin.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is completed.
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Search Alerts/Recalls
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