MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G; HAND HELD SURGICAL INSTRUMENT

Catalog Number E4971

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

The user facility reported blue flecks appearing in the patient's eye during surgery.The doctor irrigated and removed some of the flecks; however some remained in the eye.The initial post-op visit reported the patient was fine.Information on the second post-op visit has been requested, but has not been received by the reporting facility.

• Brand Name: STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G
• Type of Device: HAND HELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY 14609
• Manufacturer Contact: sharon spencer, director ; 50 technology; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3720652
• MDR Text Key: 4233312
• Report Number: 1920664-2014-00016
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E4971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR