Device Problems
Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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.(b)(4).
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Event Description
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The reporter indicated the surgeon used a viscoelastic that was tearing icl implantable collamer lens during the loading process.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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Corrected data: the reporter indicated that the surgeon used a viscoelastic that tore the icl; implantable collamer lens.The reporter also stated that "the icl is pushed back out of the implanter towards the plunger entrance end due to the high viscosity on the hyaline".Additional information has been requested but none have been forthcoming.Claim# (b)(4).
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Manufacturer Narrative
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Corrected data: claim# (b)(4).
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Search Alerts/Recalls
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