Model Number LI61AO |
Device Problem
Failure to Unfold or Unwrap (1669)
|
Patient Problems
Vitrectomy (2643); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 01/23/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
According to the reporter, the lens was discarded and is not available for evaluation.Investigation of this event is in progress.Upon completion of investigation, a follow-up report will be submitted.
|
|
Event Description
|
The physician attempted to inject an intraocular lens in the patient''s eye and allegedly, the haptic did not open and remained stuck to the lens.In order to remove the lens, the incision was enlarged, an anterior vitrectomy followed by sutures was performed.Surgery time was also extended.The physician successfully loaded a replacement lens of unknown model and diopter but decided not to implant.It is unclear why the patient is left aphakic.A follow up appointment is scheduled.Additional information has been requested and not received.
|
|
Event Description
|
Additional information received indicating that the patient had high intraocular pressure two days after surgery and was sent home with more medication.Patient is to have another iol implanted in the future.
|
|
Manufacturer Narrative
|
Although requested, the lens was not returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Additional information has been requested and not received.Based on the information provided a root cause for the reported event could not be conclusively determined.
|
|
Search Alerts/Recalls
|