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

Model Number TABLETOP

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Excessive Tear Production (2235)

Event Date 09/01/2018

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.Rapid progression of the epiretinal membrane after intravitreal aflibercept injection ji min kwon, md, myung shin lee, md, kang yeun pak, md, hyun woong kim, md, phd j korean ophthalmol soc 2018:59(10):98-988 issn 0378-6471 (print) issn 2092-9374 (online).The manufacturer internal reference number is: (b)(4).

Event Description

A literature report indicated a patient experienced a retinal pigment epithelial tear, in the left eye, 10 days following pars plana vitrectomy to repair epiretinal membrane.Subretinal fluid and cysts were observed at the side part of concave by oct.An intravitreal injection was performed.After the injection, only cicatrix was left in the part of concave and it has been stabilized.

Manufacturer Narrative

A literature case was reported which referred to a patient suffering from retinal epithelium tear after ten days of surgery involving the system.No further information has been received.The system serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8069660
• MDR Text Key: 127124952
• Report Number: 2028159-2018-02391
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AFLIBERCEPT INJECTION
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR