Model Number AT52AO |
Device Problem
Malposition of Device (2616)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
Injury
|
Event Description
|
It was reported that lens is "stuck in distance position" and is not moving in the patient's eye as it should.The surgeon indicated that the likely cause of the event was iol too long.The patient's current prognosis was reported as "iol is stuck, needs exchange for shorter lens".This report refers to the patient's left eye.
|
|
Manufacturer Narrative
|
Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.
|
|
Manufacturer Narrative
|
The lens was returned to b&l.Visual inspection found portion of the optic and trailing plate missing.Due to the condition in which the lens was returned further testing could not be performed.The lot number of the lens was not provided.Therefore a device history review (dhr) could not be conducted.Based on the current info, the specific root cause of the event could not be determined.However, the surgeon indicated that the cause might be that the iol is too long.
|
|
Event Description
|
Additional info: the lens was explanted.
|
|
Search Alerts/Recalls
|