Model Number IOLMASTER 500 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Tidal Volume Fluctuations (1634)
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Patient Problem
No Code Available (3191)
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Event Date 05/01/2014 |
Event Type
Injury
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Event Description
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The customer reported that a technician had selected the wrong surgeon's name in the iol calculation screen in the iolmaster 500.The operating surgeon did not notice that the printout reflected another surgeon's ac lens in his preferred lens column.As a result, the operating surgeon chose the wrong lens and lens power for his patient.The patient's pre-operative visual acuity: 20/40 best corrected and 20/60 (with glare testing) uncorrected.The patient's post-operative visual acuity: 20/20 best corrected and 20/25 +2 uncorrected.The patient's stable post-operative refraction: +2.00 + 0.50 x 180.The difference from target refraction: +2.25 ds.The operating surgeon performed a follow-up surgery to explant the unintended iol and implant the intended iol.
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Manufacturer Narrative
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A field service engineer (fse) performed an on-site examination of the iolmaster 500.All parameters that influence measurement were within specification.Two parameters which do not influence these measurements were out of specification and adjusted to within specification.The manufacturer reviewed the iol calculation printout and found the calculations performed by the iolmaster 500 were correct.When the iolmaster 500 is used by a number of different surgeons it is recommended to create surgeon specific records in the lens manager.The use of the lens manager is described in the software user manual on page 21 and 22.The site reported that they have implemented a cross-checking protocol in their workflow to safeguard against recurrence of the reported user error problem.The site contact is the same as the initial reporter.
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Search Alerts/Recalls
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