ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
|
Back to Search Results |
|
Model Number TABLETOP |
Device Problem
Inability to Irrigate (1337)
|
Patient Problems
High Blood Pressure/ Hypertension (1908); Anxiety (2328); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 09/12/2022 |
Event Type
Injury
|
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).
|
|
Event Description
|
A physician reported that during a combined phacoemulsification and vitrectomy surgery for retinal detachment while using an ophthalmic console at the start of the sculpture, in the first groove in the lens, there was sudden hypothalamy (sic) with irreducible anterior incarceration /luxation of the lens.Surgeon suspect that the hypothalamy from an anterior thrust of the vitreous by increase of the patient's blood pressure.Later it was noticed that the irrigation from the console was off.Irrigation was reactivated however the patient has experienced rupture of posterior capsule (pc) and anterior capsule (ac).Followed by all these events patient had also experienced psychological traumatism and anxiety about the subsequent secondary implantation.Additional information has been requested.But none received till date.Additional information received clarified that the ophthalmic phacoemulsification (phaco) tip was also involved in the procedure, the phaco tip was clogged and a milky white solution came out of the tip.
|
|
Manufacturer Narrative
|
No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.The system found to meet all cosmetic and performance standards per the service test procedure (stp).A system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|
|
|