Model Number B1PY (+25.00 D) |
Device Problem
Sharp Edges (4013)
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Patient Problems
Failure of Implant (1924); Capsular Bag Tear (2639)
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Event Date 03/01/2023 |
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.Note: delayed emdr submission was due to fda esg webtrader account system software issues, per fda esg help desk ticket # (b)(4).Hoya due diligence is documented under internal (b)(4).Posterior capsule rupture is indicated as a potential adverse event related to iol implantation, as covered under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: 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 posterior capsule rupture, explantation lens stuck to capular bag and tore thebag; caused surgeon to need toperform a vitrectomy.
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Event Description
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Intra-operative complications.Posterior capsule rupture, explantation.Lens stuck to capular bag and tore the bag; caused surgeon to need to perform a vitrectomy.
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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 additional information not available/included in the initial report.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b1py).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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Search Alerts/Recalls
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