MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED M-PORT SI INJECTOR; INTRAOCULAR LENS GUIDE

Model Number EZ-28

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.It is to be noted that our emdr server was down the day the initial mdr was due.This issue has been addressed and the server is now working.A physical copy of the initial mdr was sent via fedex tracking (b)(4) on (b)(6) 2015.

Event Description

It was reported that a small approximately 3mm plastic looking piece came out of the inserter and went into the patient''s eye during lens insertion.The piece was intraoperatively removed and the lens remains implanted and no complication were reported.

Manufacturer Narrative

The inserter and particle were not returned for evaluation.Therefore, the source and identity of the particulate could not be determined.The lot number of the inserter was not received; therefore, a lot history review could not be performed.Based on the information received a definitive root cause can not be determined.

• Brand Name: M-PORT SI INJECTOR
• Type of Device: INTRAOCULAR LENS GUIDE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5055374
• MDR Text Key: 24981196
• Report Number: 1313525-2015-02602
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• 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