|
Model Number MXUT275 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Blurred Vision (2137); No Code Available (3191)
|
Event Date 12/11/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The product evaluation has been completed.One intraocular lens (iol) was returned wrapped in a piece of foam that was inside a plastic bio-hazard bag.The original packaging was not returned.The part number and serial number were not able to be verified.However, the returned lens does have the appearance of the iol reported in this case.Particulates, saline dentrites and dried solutions were visible on the optic.Visual inspection found the lens was in three pieces.The optic had been cut or torn into sections.One haptic was attached to two different pieces of the optic, and one haptic was bent.The delivery device was not returned.The cause of the damage could not be determined, and functional testing was not able to be performed due to the damage.The product evaluation could not verify the failure mode.This investigation is in progress, and a follow up report will be submitted upon completion of the investigation.
|
|
Event Description
|
It was reported that approximately one-month post-implantation in the right eye, the orientation of the intraocular lens (iol) changed from 165 degrees to 40 degrees.The lens was rotated, then explanted and replaced with an iol of the same model and different dipoter.An intraocular injection was administered of 1% lido and epi 1:4.The original procedure was not complicated in any way, and the iol optic was clear and free of debris/deposits.However, the patient reported that their vision was always blurred.Mild early posterior capsule opacification (pco) was observed.In the physician's opinion, the likely cause of the event was that the toric lens rotated even with capsular tension ring (ctr).At this time, residual astigmatism is not worse than prior to surgery.Patient plans to wear glasses.
|
|
Manufacturer Narrative
|
Additional information: g4, h10/11.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There have been no other complaints for this lot to date.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.
|
|
Search Alerts/Recalls
|
|
|