Model Number NC1-SP (+19.50 D) |
Device Problems
Optical Distortion (3000); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.Posterior capsule opacification (pco) 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).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)(4) model: nc1-sp).There were no abnormalities on the sterilization records of the lot.(eq026).Exact root cause was not determined.However, from our investigation, we believe the event is not related to 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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Event reported in austria.Post-operative complications - pco.Reported as 9 months after implantation.Patient impact: unknown; insufficient information.
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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 the usa.Event occurred in austria and was initially assessed as a reportable event based on the available reported information.After an individual medical assessment was conducted, corrections to the initial report were noted as outlined below.Updated information as of (b)(6) 2022 indicated that no negative impact on the patient's health occurred.The patient had expressed concerns about avoiding a pco after his recent iol implantation.Therefore, the event has been re-assessed as not reportable in austria, the country of origin.
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Event Description
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Event reported in austria.Date of implant - not provided.Post-operative complications - pco.Reported as 9 months after implantation.Patient impact: unknown; insufficient information.(b)(6) 2022 updated information with reportability reassessed to not reportable in austria, as noted below.Post operative complications, after-cataract, were previously reported.(b)(6) 2022: the case will be assessed non-reportable as no patient impact was reported and the main patient's questions and concern had been addressed by individual medical assessment.Per individual medical assessment: the patient's main concern was about avoiding a pco after his recent iol implantation.This concern was addressed.Pco is a known potential ae and treatable.No negative impact on patient's health was reported.Malfunctions and defects of the devices are being monitored.All trends, when observed, are and will be reported.
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Search Alerts/Recalls
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