Model Number VICM5_13.2 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
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Patient Problem
Halo (2227)
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Event Date 11/13/2023 |
Event Type
Injury
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Event Description
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The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -7.50 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.It was reported that the patient has low vaulting with rotation, the lens had tore during injection/delivery into the eye, and the patient has glare/haloes.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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B5: the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2; -7.50 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.It was reported that the patient has low vaulting with rotation, the lens had tore during injection/delivery into the eye, and the patient has glare/haloes and the lens was decentered.On (b)(6) 2023 the lens was exchanged with a same length/power lens and this resolved the problem.Claim#: (b)(4).
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Manufacturer Narrative
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H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
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Manufacturer Narrative
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H3 - device evaluation: lens was returned in a vial in liquid.Visual inspection found the lens haptic broken.Dimensional inspection was unable to be performed due to significant lens damage.Claim#: (b)(4).
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Search Alerts/Recalls
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