Model Number CC4204A |
Device Problem
Contamination /Decontamination Problem (2895)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
|
|
Event Description
|
Reportedly, a cc4204a intraocular lens, diopter +26.5 was not used due to the surgeon saw a "dark spot" on the lens.Reporter states that a back-up lens was used instead.This occurred on (b)(6) 2019.Attempts to obtain additional information have not been successful.
|
|
Manufacturer Narrative
|
H3-device evaluation: the lens was returned in liquid, in a lens case/vial.Visual inspection found no visible damage to the lens.The lens was inspected under 10x and 20x power and no black spot was noted.Claim# (b)(4).
|
|
Search Alerts/Recalls
|