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

Model Number CUSTOM PAK

Device Problem Defective Component (2292)

Patient Problem Capsular Bag Tear (2639)

Event Date 02/27/2014

Event Type  Injury  

Event Description

A surgeon reported that a posterior capsular tear occurred during the phaco portion of a cataract procedure.The surgeon did not known that the phaco micro tip was defective and not smooth.Therefore, it tore the posterior capsular bag.The product was replaced to continue the procedure.An anterior vitrectomy was performed and the procedure was completed addition information and product sample have been requested for this case.No updates have been received despite attempts made to obtain information.

Manufacturer Narrative

Evaluation summary: additional information and product sample have been requested for this case.No updates have been received despite attempts made to obtain information.There was no 0.9 m 45k tapered phaco tip was returned for causing a posterior capsular tear.There was no lot number was identified with this complain; 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).

• 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 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3766938
• MDR Text Key: 4552307
• Report Number: 1644019-2014-00059
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/04/2014
• 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
• Patient Outcome(s): Required Intervention