Model Number 550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 01/27/2023 |
Event Type
Injury
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Event Description
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A healthcare professional reported a patient with capsular tear during cataract procedure.Two parallel and clear white lines appeared in the optical coherence topography image and the anterior chamber depth of the patient was 4.15 mm.During laser fire poor cooperation of patient leads to negative pressure loss and action time was prolonged, the tearing capsule was not complete and changed to manual tearing of the capsule and the incision was not fully opened and replaced by manual incision.
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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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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 received, reported event updated from capsular tear to incomplete dissection.
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Manufacturer Narrative
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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.Service history was reviewed for the system.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.The customer reported event cannot be confirmed.Thus, based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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