Catalog Number 8065817301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Capsular Bag Tear (2639)
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Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that during cataract surgery, two patient's experienced posterior capsule ruptures.The surgeon indicated the ia handpiece was leaking.This report is for one patient.
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Manufacturer Narrative
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The customer did not return a sample for an evaluation.Two photos were provided with the complaint file.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.The handpiece was manufactured in october 2017.The photo provided with the complaint file was reviewed.The photo shows the posterior end of the handpiece with the identification for a curved.3mm reusable single piece handpiece.No conclusions can be made about the complaint issue for leakage based on the photo.Because a sample was not returned and the review of the lot information indicates the product was released to the product¿s acceptance criteria, the root cause for the customer complaint issue cannot be determined.The most likely causes for the leakage is from poor fit with the tubing or damage to the tip.All reusable handpieces are 100% visually inspected and functionally tested during the manufacturing process.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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