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

Catalog Number 8065751763

Device Problems No Audible Alarm (1019); Use of Incorrect Control/Treatment Settings (1126); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Disturbances (2140); Eye Burn (2523); No Code Available (3191)

Event Date 03/23/2015

Event Type  Injury  

Event Description

An ophthalmic surgery room supervisor reported that a patient experienced corneal burn during cataract surgery.This patient was the seventh patient of the day.The affected eye was the left eye.The event occurred at the beginning of the sculpt phase of the lens nucleus.There was an occlusion signal during 5 seconds but without sound signal.The surgeon did not hear any occlusion alarm.The sound intensity of the occlusion alarm was set very low on the machine.In surgeons opinion the occlusion of the handpiece with the viscoelastic contributed to the event.The surgeon specified that he observed incision burn at the beginning of the phaco and milky transformation of the viscoelastic.The surgeon specified that before entering the probe, he removed a quarter of viscoelastic and cleaned the masses.Then he started the sculpt step in torsional movement.He did not performed the pre-phaco step.The surgeon did not change the probe and continued the surgery but during 30 to 40 seconds he had occlusion difficulties and it heated the incision.The patient had important postoperative astigmatism since the surgeon had to apply 2 sutures.The surgeon could not remove the sutures too early.The burnt part of the cornea had not been recovered at the time of this report.Due to the event the patient also had descemet folds and wound leakage.The patient was not hospitalized due to the event and no additional surgery was needed.The facility also informed that they respected the viscoelastic delay at room temperature prior to surgeries.The viscoelastic was at room temperature when used.The bss was not cold.The surgeon had the intelligent phaco function deactivated for sculpture.During the surgery the patient´s eye level versus the cassette level was the same.The facility examined the handpiece used for the surgery and did not seem occluded.The facility did not recently change their cleaning and sterilization procedure.They also reported that they were using kelman tips before but now they are using balance tips no additional information is expected.This is one of six reports being filled for this facility.This report is for the system and the second patient with corneal burn.

Manufacturer Narrative

A service visit was performed.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.No further information is expected.(b)(4).

Manufacturer Narrative

Evaluation summary.A clinical analyst reviewed this complaint and stated the following: corneal thermal injuries are typically related to excessive heat generated by the phaco tip due to insufficient aspiration flow, extended energy application, or combination of both.The system is designed to cool the phaco tip during use as aspirated fluid flows through the tip lumen.Overheating of the phaco tip, however, may occur due to extended application of ultrasonic energy or compromised aspiration flow through the phaco tip.Reduced fluid flow through the phaco tip may be caused by phaco tip re-use, tip clogging by nuclear material, kinked tubing, inadequate flow and vacuum settings, or obstruction by ophthalmic viscoelastic device (ovd).When the phaco tip is occluded, infusion will cease, reducing the cooling effect of the tip.Occlusion tones (intermittent beeping tones during occlusion) alert the user, indicating that the vacuum is near or at its preset limit, and aspiration flow is reduced or stopped.The surgeon must recognize the occlusion tones and manually stop the ultrasound mode in order to prevent a rapid temperature increase.A company service representative examined the system.The system was tested and confirmed to function as intended.The system was then tested and met all product specifications.The product met specifications at the time of release.The associated handpiece (hp) was returned for evaluation.Both visual and functional testing found the handpiece to meet specifications.The ground resistance was found to meet specifications.The hp was then connected to a calibrated system and primed and tuned without any nonconformities.The hp was run at 100% power for 5 minutes and no abnormalities were observed.Finally, u/s and torsional stroke was measured and was verified to meet specifications.For the custom pak the device history record (dhr) was review and did not show any abnormalities.Also no remarks were made during the manufacturing process of this lot.The sterilization cycle was checked for this specific custom pak lot and no abnormalities were reported.No complaint sample was received.For the consumable product the review of the dhr indicates the order was built to specification.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.A root cause cannot be determined.The handpiece sample was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.For the custom pak and the consumable products no sample was received and the root cause could not be determined.(b)(4).

• Brand Name: CENTURION 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: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4693246
• MDR Text Key: 19635887
• Report Number: 2028159-2015-05636
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Other Device ID Number: 2.03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• 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: OZIL TORSIONAL PHACO HANDPIECE; CUSTOM PAK; DUOVISC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR