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Model Number MX60UT |
Device Problems
Material Opacification (1426); Material Integrity Problem (2978)
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Patient Problem
Visual Impairment (2138)
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Event Date 10/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
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Event Description
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The surgeon is reporting that glistening and/or cloudiness was observed on an implanted lens one day post-surgery.The lens was implanted in the patient's left eye.Reportedly, the surgeon also noted a lathing pattern on the lens.Initially, there were no visual disturbances (patient's vision was measured as j1 with no blurriness).At the one week post-op mark, however, the patient's vision had decreased to 20/50.As a result, the lens was explanted and replaced with another toric lens of a different model.The replacement lens had the same diopter power as the initial lens, but slightly less cylindrical power.The surgeon attributes the decreased vision to the lens.Following the lens exchange, the patient is said to be much better.The patient's vision was measured as j1 once more.
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Manufacturer Narrative
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The explanted lens was evaluated by an outside specialist contracted by b+l.On the surface of the lens, deposits appearing to correspond to dried balanced salt solution material and protein deposition were observed.Furthermore, manufacturing lathe lines were observed under light microscopy.No glistening, sub-surface nano-glistening, or evidence of lens opacification was observed during analytical testing.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, a root cause for the reported event could not be conclusively determined.It should be noted that actions were initiated at the manufacturing site to investigate the device manufacturing process.
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Search Alerts/Recalls
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