Model Number 254-E (+19.00 D) |
Device Problem
Sharp Edges (4013)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 09/08/2022 |
Event Type
Injury
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Event Description
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Event occurred in south africa.Intra-operative complications - posterior capsule rupture.
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Manufacturer Narrative
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This initial emdr is being submitted to fda for outside us like products reporting."posterior capsule rupture" is indicated as a potential adverse event related to iol implantation in hoya ifu covered under the warnings section.Manufacturer's codes for: type of investigation, findings, and conclusion are pending 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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Event occurred in south africa.Intra-operative complications - posterior capsule rupture.
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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 outside of the usa.The report includes corrected information and additional information not available/included in the initial report.The product was 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: 254-e).From our investigation, we couldn't confirm the reported event about posterior capsular rupture.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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