Model Number VICMO13.2 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
|
Patient Problems
Intraocular Pressure, Delayed, Uncontrolled (1936); No Code Available (3191)
|
Event Date 02/09/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
This product is manufactured in the u.S.But not marketed in the u.S.Patient code: secondary surgical intervention, lens explanted and exchanged shorter lens.(b)(4).
|
|
Event Description
|
The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -10.00 diopter, in the patient's right eye (od) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due excessive vaulting and elevated intraocular pressure (iop).The lens was exchanged for a shorter lens and the problem was resolved.
|
|
Manufacturer Narrative
|
Device evaluation: the lens was returned dry in a micro centrifuge vial with residue on the product.Visual inspection found the lens haptic torn and the torn haptic piece missing.There was presence of residue on the lens surface.(b)(4).
|
|
Search Alerts/Recalls
|