Model Number VICMO12.1 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)
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Patient Problems
Loss of Vision (2139); No Code Available (3191)
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Event Date 11/10/2014 |
Event Type
Injury
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Event Description
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The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014.The reporter indicated the lens had a low vault and there was loss of best-corrected visual acuity.The surgeon is planning on explanting the lens and exchanging for a longer lens.The lens remains implanted.The patient's current post-op best-corrected visual acuity is 20/30.
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Manufacturer Narrative
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This product is manufactured in the u.S.But not marketed in the u.S.Pt weight: unk.Explant date: na.(b)(4).Device evaluated by manufacturer? no.Lens implanted.Method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions: (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).Lens implanted.
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Manufacturer Narrative
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Medical review - according to use fmea (failure modes and effect analysis) it has been determined that inadequate vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition; poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular sulcus or ciliary sulcus cyst, etc).Staar recommends the icl to be left implanted if no cataracts are noted or in cases where there is a trace anterior subcapsular cataract with no progression.Staar believes that the action to remove and/or replace the icl increases the risk for anterior subcapsular cataract.Based on the complaint history, work order search and medical review, a specific root cause of the event could not be determined.(b)(4).
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Manufacturer Narrative
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(b)(4).Results: visual inspection of the returned product found one haptic torn.The lens was returned in liquid.The lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.Conclusion: based on the complaint history, work order search, medical review and the evaluation of the returned product, a specific root cause of the event could not be determined.Claim # 707256.
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Event Description
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Additional information received - the lens was explanted in the last week of (b)(6) 2015 and was exchanged for a longer lens.The lens exchange resolved the problem.
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Search Alerts/Recalls
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