MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problems Nonstandard Device (1420); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A surgeon reported that during multiple cases it was noticed that the ultra sleeves from the custom packs varied in the thickness and seemed inconsistent in size.It was reported that the difference of the size was obvious upon visual inspection.The surgeon proceeded to use the sleeves during treatment of the nucleus and suggested that the amount of irrigation supply was obviously different when rotating the handpiece at 360 degrees.Add'l info has been requested for this case; however, no add'l info is available.There is no sample available for eval.

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 add'l reportable info becomes available.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4097951
• MDR Text Key: 18002517
• Report Number: 1644019-2014-00164
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ULTRASONIC INFUSION 0.9MM; PAK; CUSTOM PAK