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

Model Number EZ-28V

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the surgeon started advancing the lens in the eye and it ejected out the side of the injector.The lens was not completely implanted.The surgeon removed the lens and injector and implanted the backup lens with no issue.Additional information has been requested, but no additional information has been received.

Manufacturer Narrative

The lens was returned to b+l.Visual inspection found the tip bent and split up the sides.The lens is protruding from the sides of the split tip.Both haptics are bent.There is a small amount of dried solution visible in the loading deck but none in the tip.Due to the condition in which the inserter was returned further testing could not be performed.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.The exact cause of the reported event could not be conclusively determined.However, it is possible that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

Event Description

Additional information: this event pertains to the patient's left eye.The patient's current status was described as "fine".

• Brand Name: M-PORT SI INJECTOR
• Type of Device: INTRAOCULAR LENS GUIDE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5938376
• MDR Text Key: 54267032
• Report Number: 0001313525-2016-00389
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2017
• Device Model Number: EZ-28V
• Device Lot Number: H651001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2016
• 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 Age: 75 YR