MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Macular Edema (1822)

Event Date 01/01/2010

Event Type  Injury  

Event Description

A literature article unexplained visual loss after gas tamponade for macula on retinal detachment was received identifying the incidence rate and the clinical characteristics of unexplained visual loss after gas tamponade for primary macula-on rhegmatogenous retinal detachment.All subjects underwent a vitrectomy with gas procedure for the repair of retinal detachment.The outcome was unexplained visual loss after gas absorption in nine eyes.All patients had a central scotoma and microcytic macular edema.Endoillumination was set at thirty five percent.Perfluorocarbon liquid (pfcl) was used with retinopexy using cryopexy therapy.Standard medication included topical steroid and antibiotic association four times a day for 3 weeks and 1% tropicamide.This is the second of three reports for the fourth patient.

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.Lorenzo iuliano, md, eleonora corbelli, md, andrea ramoni, md, francesco bandello, md, marco codenotti, md, unexplained visual loss after gas tamponade for macula-on retinal detachment.Incidence and clinical characterization.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause cannot be determined conclusively.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).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13389975
• MDR Text Key: 284684351
• Report Number: 2028159-2022-00109
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; OCTAFLUOROPROPANE (C3F8); SULFUR HEXAFLUORIDE (SF6)
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male