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

Catalog Number 8065751763

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

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.Additional information has been requested but not received to date.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that cavitational bubbles appeared during several cataract procedures with intraocular lens implant.Additional information has been requested but not received to date.

Manufacturer Narrative

The previously reported system did not apply and has been corrected due to the additional information received.Evaluation summary: 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 cavitation only occurred with the hard cataract program.The power was set at 95, and the cr set it back to 85.As the customer did not retain the finished goods pak lot number, the device history record could not be reviewed.The customer did not retain a sample; visual inspect or functional testing could not be conducted.The troubleshooting guide in the operator's manual states that for the symptom of air in irrigation line causing bubbles, the probable causes are: drip chamber not sufficiently full; air in line or handpiece; loose irrigation luer fitting; improper priming.Recommended solutions: fill drip chamber 2/3 to 3/4 full.Flush irrigation line in free flow or foot pedal position 1.Tap handpiece 2-3x during flow test.Check irrigation line and reseat.Reprime per setup procedure.The root cause cannot be determined conclusively.

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5450291
• MDR Text Key: 39203386
• Report Number: 2028159-2016-00759
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121555
• 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: 04/12/2016

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 Catalogue Number: 8065751763
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• 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