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

Model Number EZ-28

Device Problems Material Rupture (1546); Malposition of Device (2616)

Patient Problem Rupture (2208)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the capsule ruptured unexpectedly causing the haptic to sublux and to not seat properly in the sulcus.The incision was enlarged to remove the lens from the patient's left eye and another anterior chamber lens was implanted successfully.This report references the delivery device used during the procedure.

Manufacturer Narrative

The delivery device was not returned to b+l for evaluation; therefore, product evaluation could not be conducted.The lot number of the delivery device was not provided; therefore, a device history record (dhr) review could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively 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: 5102723
• MDR Text Key: 26726824
• Report Number: 0001313525-2015-02640
• 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: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EZ-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR