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

Model Number TABLETOP

Device Problems Air Leak (1008); Collapse (1099); Decrease in Pressure (1490)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2016

Event Type  malfunction  

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.(b)(4).

Event Description

A customer reported that during a procedure, the patient's intraocular pressure (iop) decreased which lead to the globe collapsing.The event occurred during the transition of fluid eye to air (fax).The operating perimeters were as follows: iop 20mmhg, fax 35mmhg.The surgeon was using a vacuum of approximately 150-200mmhg when he noticed the eye collapsing.The vitrectomy cutter was in the off position.The surgeon went back to fluid infusion to inflate the eye.During this stage, fluid flowed into the globe followed by some air bubbles then fluid again, via the infusion line.Once good global pressure, 2mmhg was established, the surgeon proceeded to perform the fax and did so successfully.The case was then completed.There is no known harm to the patient.

Manufacturer Narrative

A company clinical analyst reviewed this case and stated the following: ¿the customer reported that during surgery the patient's intraocular pressure (iop) decreased which lead to the globe collapsing.The event occurred during the transition of fluid to air exchange (fax).The operating perimeters were as follows: iop 20mmhg, fax 35mmhg.The surgeon was using a vacuum of approximately 150-200mmhg when he noticed the eye collapsing.The vitrectomy cutter was in the off position.The surgeon went back to fluid infusion to inflate the eye.During this stage, fluid flowed into the globe followed by some air bubbles then fluid again, via the infusion line.Once good global pressure, 2mmhg was established, the surgeon proceeded to perform the fax.The surgery was completed successfully.There is no known harm to the patient.Intraocular surgery has always been recognized to induce substantial intra-ocular pressure (iop) fluctuations, this is true for both anterior (i.E.Cataract surgery) and posterior segment (i.E.Vitrectomy) surgeries.Acute ocular hypotony is common during many intraocular surgeries.Intra-operatively, maintenance of eye pressure is a balance between infusion (irrigation) and extrusion (aspiration) with both parameters actively controlled by the surgeon and with the advent of iop control features, supported by vitrectomy/phaco machines.Hypotony (<5mmhg) is in fact fairly common in eye surgery that most eye surgeons anticipate this to occur during surgery.Surgeons have been trained to recognize and mitigate this by adjustment of the previously mentioned parameters be it manually or through the machine to adapt to what is being performed during surgery.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 system was manufactured on june 20, 2016.A review of the manufacturing records in did not reveal any related non-conformity during manufacturing for this system.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6128888
• MDR Text Key: 61234102
• Report Number: 2028159-2016-05407
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 4.00.168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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
• Patient Outcome(s): Other