MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STELLARIS ULTRASOUND HANDPIECE

Catalog Number BL3170

Device Problem Device Issue (2379)

Patient Problem Eye Burn (2523)

Event Date 05/12/2014

Event Type  Injury  

Event Description

User facility in (b)(6) reported the pt sustained a corneal burn during phacoemulsification procedure.Add'l info was received stating three sutures were required to close the wound.No further medical intervention was required.The pt has achieved 6/6 vision with no add'l cylinder in astigmatism.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY 14609
• Manufacturer Contact: sharon spencer, dir ; 50 technology; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3876011
• MDR Text Key: 19484435
• Report Number: 1920664-2014-00081
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BL3170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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): Required Intervention