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 Intraocular Pressure Increased (1937)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of risk factors for early ocular hypertension after microincision vitrectomy surgery.Li jie, liu san-mei, li fang, dong wen-tao, zhong jie (department of ophthalmology, sichuan academy of medical sciences & sichuan provincial people's hospital, chengdu, 610072, sichuan).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.(b)(4).

Event Description

A literature report was received discussing the effects of the incidence in high intraocular pressure (iop) after microincision vitrectomy in patient's (both male and female) with a various types of vitreoretinal diseases.The report indicated high iop occurred in 26 eye within one week of surgery.21 eyes returned to normal within one week after treatment with local drops of anti-inflammatory and decreased iop.Three eyes returned to normal within one month.Local drug control of iop was not effective in two eyes and glaucoma trabeculectomy and peri-iridotomy were performed.For patients with postoperative iop raging from 31-30mmhg, non steroidal and glaucoma drops were selected for use.For patients with 30-40mmhg were given orally with anti-hypertensive liquid simultaneously.For patients greater than 40mmhg combination of "hyperosmolat" agent and , and when drug treatment effect is not good, symptomatic treatment such as preoperative atrial puncture may be performed.This file is for the report of 24 patients with various ranges of intraocular pressure.

Manufacturer Narrative

A literature report was received discussing the effects of the incidence in high intraocular pressure (iop) after micro incision vitrectomy in patients with a various types of vitreoretinal diseases.The report indicated high iop occurred in 26 eye within one week of surgery.Twenty one (21) eyes returned to normal within one week after treatment with local drops of anti-inflammatory and decreased iop.Three (3) eyes returned to normal within one month.Local drug control of iop was not effective in two eyes and glaucoma trabeculectomy and peri-iridotomy were performed.For patients with postoperative iop ranging from 31-30mmhg, non-steroidal and glaucoma drops were selected for use.For patients with 30-40mmhg were given orally with anti-hypertensive liquid simultaneously.For patients greater than 40mmhg combination of hyperosmolar agent and if the drug treatment effect is not good, symptomatic treatment such as preoperative atrial puncture may be performed.This file is for the report of twenty-four (24) patients with various ranges of intraocular pressure (iop).Transient intraoperative pressure (iop) fluctuation is recognized as a common occurrence during vitreoretinal eye surgery.Most vitreoretinal surgeons have been trained during their fellowship to recognize and mitigate intraoperative hypotony by adjustment of the infusion pressure and vacuum level via the console footswitch.Intraoperative, transient high intraocular pressure is not an injury.It is a potentially hazardous condition, dependent on the extent of the high iop, which must be properly managed by the surgeon.This is a temporary condition dependent on the management of infusion and vacuum levels used during surgery.During surgery, the actual measurement of the iop is rarely performed.Vitreoretinal surgeons, however, are trained to assess the iop by the visual observation of the cornea, perfusion of retinal vessels, and tactile feel of the firmness of the globe.As stated in the system operators manual: ¿the closed loop system that adjusts iop cannot replace the standard of care in judging iop intraoperatively.The surgeon must continue the common practice of informally judging the following: finger palpation on the globe, tactile feedback of the surgical instruments, retinal vessel perfusion/pulsations, and presence of corneal edema.If the surgeon believes the iop is not responding to the system settings and is dangerously high, the surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): close the infusion stopcock, pinch the infusion line, remove the infusion line.¿ no further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.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
• MDR Report Key: 8069735
• MDR Text Key: 127122935
• Report Number: 2028159-2018-02395
• 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
• Report Date: 02/11/2019

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
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUREPOINT; PUREPOINT
• Patient Outcome(s): Required Intervention