MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER ULTRAFLOW II I/A HANDPIECE; CATHETER, IRRIGATION

Catalog Number 8065751795

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

A doctor of ophthalmology reported that an irrigation / aspiration handpiece would not build vacuum during a procedure.The handpiece was exchanged to complete the case.There was no patient harm.

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.

Manufacturer Narrative

Additional information: no handpiece was received for the vacuum not building during its use.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.Because a sample was not returned and no lot information was provided for a lot record review, the root cause for customer complaint issue cannot be determined.(b)(4).

Manufacturer Narrative

One company handpiece was returned for the vacuum not rising during surgery.For this complaint file, the final customer lot was identified as lot 984823m, manufactured in october 2014.A device history record review for the handpiece lot was conducted.No anomaly was found during the device history record review.The product was released based on the products acceptance criteria.A complaint lot history examination indicates there are two other complaints for this reported issue.The handpiece tip was visually inspected.The handpiece is visually acceptable.A vacuum and pressure test was performed on the handpiece and the testing was deemed acceptable.The evaluation does not confirm a vacuum issue with the handpiece.The handpiece was visually and functionally conforming.The root cause for customer complaint issue cannot be determined.(b)(4).

• Brand Name: ULTRAFLOW II I/A HANDPIECE
• Type of Device: CATHETER, IRRIGATION
• 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 ; mail stop ab2-6; mail stop r3-48; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 4811405
• MDR Text Key: 5916160
• Report Number: 2028159-2015-06257
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K910245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

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: 8065751795
• Device Lot Number: 984823M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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: ULTRAFLOW II I/A HANDPIECE
• Patient Outcome(s): Other