Model Number VICM5_13.2 |
Device Problems
Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Blurred Vision (2137)
|
Event Date 11/01/2023 |
Event Type
Injury
|
Event Description
|
The reporter indicated that a 13.2mm, vicm5_13.2, -8.0 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.Refractive surprise was observed.Lens remains implanted.Cause of the event is reported as patient related factor.Additional information has been requested but none has been forthcoming.
|
|
Manufacturer Narrative
|
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
|
|
Manufacturer Narrative
|
Additional information: b1-adverse event.B2-required intervention to prevent permanent impairment/damage (devices).B5-the reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -8.00 diopter was implanted into the right eye (od) on (b)(6) 2023.Refractive surprise was reported.On (b)(6) 2024 the lens was removed and on the same day a replacement lens of a smaller size and different diopter was implanted.The replacement lens resolved the problem.D6b- (b)(6) 2024.Claim# (b)(4).
|
|
Manufacturer Narrative
|
H3: device evaluation: lens was returned not in a box, returned in a specimen cup, in liquid.Visual inspection found the lens haptic torn.Claim#: (b)(4).
|
|
Search Alerts/Recalls
|