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

Model Number TABLETOP

Device Problem Pressure Problem (3012)

Patient Problems Retinal Detachment (2047); Retinal Tear (2050); Collapse (2416)

Event Date 02/21/2020

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 surgeon reported there was a loss of infusion pressure during a procedure.The patient experienced an eye collapse and retinal tear.Additional information has been requested and received.Additional information has been received from the surgeon which indicated the patient had proliferative diabetic retinopathy (pdr) with retinal traction, and was under going a vitrectomy procedure with laser treatment for this issue.The surgery was going as planned with the expected issues of mild corneal haze, blood stuck to back surface of lens, epi retinal membrane (erm) and retinal tractions.After removal of the tractions and peeling of the erm the retina was observed to be completely flat with no obvious breaks.The patient felt some discomfort during the indentation process of the procedure so additional anesthesia was administered subtenons.The laser portion of the procedure was performed under air.The surgeon went back to fluid/air exchange (fax) and the eye suddenly collapsed.A break in the retina was observed 180 degrees opposite the inferotemporal infusion line.A small air bubble had escaped subretinally as well.A rrhegmategenous retinal detachment was noted.The break was sealed using cryotherapy and gas.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.The customer did not request service for the system.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.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company service representative (ar) examined the system on and could not replicate the reported issue.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.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
• MDR Report Key: 9853105
• MDR Text Key: 184069788
• Report Number: 2028159-2020-00249
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 06/03/2020
• Supplement Dates FDA Received: 05/04/2020; 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR