Model Number PREVUE C (+23.00 D) |
Device Problem
Sharp Edges (4013)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 10/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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This initial emdr is being submitted to fda as a reportable event that occurred in the usa."posterior capsule rupture" is indicated as a potential adverse event related to iol implantation in hoya ifu covered under the warnings section.Type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
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Event Description
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Intra-operative complications: lens was implanted then explanted due to lens decentered because of posterior capsule tear.
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Manufacturer Narrative
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This follow-up #1 emdr is being submitted to fda for a reportable event that occurred inside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: corrected to yes.Additional information: added date returned indicated company representative for investigation type of report - noted as follow-up #1 type of follow-up - noted for corrected information and additional information added codes for manufacturer's investigation: type; findings; and conclusion.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.We couldn't confi rm reported event but we found the iol was damaged.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: prevue c).The exact root cause of the event was not determined.However, based on available information, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.
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Event Description
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Intra-operative complications: lens was implanted then explanted due to lens decentered because of posterior capsule tear.
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Search Alerts/Recalls
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