Catalog Number 711.53 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Vitreous Hemorrhage (2143); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 03/01/2023 |
Event Type
Injury
|
Event Description
|
A physician reported via a clinical study that during a vitrectomy/ cataract combination surgery by using disposable ophthalmic forceps and handpieces a male patient experienced epiretinal membrane recurrence, vitreous hemorrhage and proliferative vitreoretinopathy.Patient was hospitalized and unknown intervention was given.
|
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
No lot number was identified within the study and therefore within this complaint, which is why the associated manufacturing documentation could not be reviewed.All product and batch history records are quality reviewed prior to product release, ensuring that all products on the market fulfill the relevant requirements.Since the questionnaire retrospectively collects data, no sample is available to be provided to the responsible site for an in-depth investigation.Not enough information was provided to properly complete an investigation.The root cause of this complaint could not be identified.The exact root cause for the customer¿s reported event is unknown.Therefore, no specific action can be taken.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|