Model Number CATALYS-U |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Headache (1880)
|
Event Date 11/17/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.
|
|
Event Description
|
It was reported that the catalys procedure went well in which capsulotomy / fragmentation / arcuate incisions were created.Patient was escorted from catalys room and into operating room for cataract surgery however, was slurring her words while speaking and was taken to the local emergency room.It was later learned that patient was experiencing a severe migraine and was admitted overnight for observation and discharged on (b)(6) 2022.On (b)(6) 2022, doctor completed the cataract surgery.No additional information was provided.
|
|
Manufacturer Narrative
|
Section h4: correction: in initial report, the manufacturer date provided was inadvertently reported as sept 16, 2019, however the correct date is aug 16, 2019.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Manufacturer Narrative
|
Correction: b2: correction: in initial report, the outcomes attributed to adverse event was checked off as "other serious (important medical events)" however, it should have been "hospitalization - initial or prolonged".All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
|
|
Search Alerts/Recalls
|