Model Number HOYA 255 (+24.50 D) |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/26/2022 |
Event Type
Injury
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Event Description
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Damaged haptic after implantation.The doctor explanted the iol from the eye since he noticed the trailing haptic was separated.The surgery was completed with another iol.
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Manufacturer Narrative
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This initial report is being submitted to fda for a reportable event that occurred outside the usa.Haptic damage is indicated as a potential malfunction related to the iol, as covered under the warnings section of the product's instructions for use (ifu).Manufacturer's codes for: type of investigation, findings, and conclusion are pending completion of product return and 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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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.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The iol was available for investigation.Appearance check result was consistent to reported information.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6) ; model: 255).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.Capa-22-0009 has been initiated for "damaged haptic" complaints.
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Event Description
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Damaged haptic after implantation.The doctor explanted the iol from the eye since he noticed the trailing haptic was separated.The surgery was completed with another iol.
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Search Alerts/Recalls
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