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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 06/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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H.3., h.6.: 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.Alcon lensx (site #3008772169) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center site #2028159).The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported a patient with anterior capsule tear opening incision without vitreous ascent in the right eye during cataract procedure.A three piece intra ocular lens was implanted in the sulcus normally.
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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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