Model Number X-SPM |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that it was later found that a patient's visual acuity had been unable to be properly adjusted due to axis deviation after insertion of a toric intraocular lens following the guidance displayed by the system.It is unknown if the deviation was caused by the console or the user.The patient will be scheduled to fix the deviation at a later date.Additional information received states the intraocular lens deviation was fixed and the patient has recovered.There are four related reports for this patient.This report addresses patient one and another manufacturer report will be filed for the other patients.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Data collection was received and the data was investigated.Based on the data the surgeon operated from a slightly inferior position.The selected temporal orientation on the planning screen does not match this orientation of the eye.Followed by a wrong registration proposal confirmed, this lead to a wrong toric alignment overlay.User error, the surgeon operated from a slightly inferior position, which is not available in the device and an incorrect registration was confirmed/manually set.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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