Catalog Number 8065750833 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/17/2016 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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A customer reported that during a cataract extraction with intraocular lens implant procedure the handpiece did not have phacoemulsification power.The case was completed using an alternate handpiece.There was no harm to the patient.
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Manufacturer Narrative
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The system and handpiece were examined.There was no problem found with the handpiece.The associated system was verified to meet specifications.The system was tested and found to meet product specifications.A review of complaints for the last 24 months did not indicate any additional related reports for this phaco handpiece.Based on qa assessment, the product met specifications at the time of release.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product.The phacoemulsification handpiece was found to exhibit no issues.Therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).
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Manufacturer Narrative
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The phaco handpiece was received for evaluation.A visual assessment of the returned sample found no visual nonconformities.The returned handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in with the system set at 100% ultrasonic and torsional power.The handpiece was then found to meet specifications when connected to the calibrated for stroke testing on the ultrasonic and torsional movements.Review of the data indicates that there were 3 procedures performed with this handpiece.The last recorded data displayed no tuning issues.The returned handpiece was found to meet specifications.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.(b)(4).
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Search Alerts/Recalls
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