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

Catalog Number E4971

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

The user facility reported the irrigation tip had particulate flaking off in the pt's eye.The flakes were removed with no impact to the pt.

Manufacturer Narrative

Report 3 of 4, see 1920664-2014-00147, 00148, 00150.

• Brand Name: STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G
• Type of Device: SIMCO DOUBLE BARRELED 23G I/A UNIT
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY 14609
• Manufacturer Contact: sharon spencer, dir ; 50 technology; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4060352
• MDR Text Key: 15104245
• Report Number: 1920664-2014-00149
• 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: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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