Catalog Number 8065751762 |
Device Problem
Disconnection (1171)
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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 physician reported that an ophthalmic operating console presented footswitch disconnection and no phacoemulsification power during a cataract surgery.The console triggered an alarm upon footswitch disconnection.The patient experienced a posterior capsular hole.The surgery was completed and the intra-ocular (iol) lens were implanted in sulcus with an anterior vitrectomy.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been received indicating that the physician examined the patient post-operatively.The patient's right eye had a centered intra-ocular lens (iol) in the sulcus and the suture was removed.The patient had low vision that refracts to normal with myopic lens.
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Manufacturer Narrative
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Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause of the reported event is inconclusive.The 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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