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

Model Number CUSTOM PAK

Device Problem Inadequate Lighting (2957)

Patient Problem No Information (3190)

Event Date 11/11/2014

Event Type  Injury  

Event Description

A customer reported ray of light absent or intermittent in two laser probes.Probes were changed twice but there was a delay in the procedure and surgery could not be performed.Additional information has been requested but not received to date.

Manufacturer Narrative

The device was received at the manufacturing site for evaluation.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.(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: 4337602
• MDR Text Key: 5178296
• Report Number: 1644019-2014-00204
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: MN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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?: Yes
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASER PROBE 23G
• Patient Outcome(s): Required Intervention