Catalog Number 8065750469 |
Device Problems
Energy Output Problem (1431); Suction Failure (4039)
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Patient Problems
Corneal Edema (1791); Corneal Clouding/Hazing (1878)
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Event Date 10/21/2022 |
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 a during a cataract procedure an phacoemulsification handpiece had no aspiration strength during quadrant mode and no ultrasound.Post operatively the patients experienced swollen corneas.Additional information has been requested.Additional information was received and clarified that corneal edema was persists from 7 to 10 days and resulted in corneal opacity for multiple patients.The surgery was completed however it took the surgeon much longer than usual.There was no additional medical or surgical intervention required.
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Manufacturer Narrative
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No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards per the service test procedure (stp).A system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information indicated that the suspect product was phacoemulsification handpiece.
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Manufacturer Narrative
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The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the phacoemulsification handpiece (hp) was returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The hp was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The handpiece was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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