Model Number VTICM5_12.1 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient weight, ethnicity and race- unk.Date of event- unk.Implant date- unk.Pma/510(k): 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 implanted a 12.1mm vticm5_12.1 implantable collamer lens, -11.5/+2.0/091 (sphere/cylinder/axis) into the patient's eye.On (b)(6) 2021 the lens was explanted.Attempts to obtain additional information have not been successful.
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Manufacturer Narrative
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B5-additional information: the initial lens was implanted into the patient's left (os) eye on (b)(6) 2021.The lens was explanted and replaced with a longer lens due to low vault and lens rotation.The problem was resolved.After replacement, the unaided va is 6/7.5-1.The cause of the event is reported as user error; the device did not fail to perform as intended.Claim# (b)(4).
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Search Alerts/Recalls
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