MAUDE Adverse Event Report: BAUSCH + LOMB M-PORT SI INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number EZ-28V

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2016

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 after loading and attempting to advance the lens into the eye, the injector¿s tip split/separated.Reportedly this occurred with two injectors during the same procedure.There was no contact with the patient.The surgeon re-loaded the lens into another injector and successfully completed the case without issues.

Manufacturer Narrative

Additional information: device manufacture date, additional mfr narrative.The product evaluation found the tip split up on one side.Very little dried solution was visible in loading deck and tip.Review of device history record (dhr) indicated no anomalies.Based on available information, a root cause for the reported event could not be conclusively determined.However, operational context due to operator technique such as improper loading of lens or incorrect amount of viscoelastic used may have caused or contributed to the reported failure mode.

• Brand Name: M-PORT SI INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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: 6139273
• MDR Text Key: 61298209
• Report Number: 0001313525-2016-00711
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2017
• Device Model Number: EZ-28V
• Device Lot Number: H660402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• 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 Outcome(s): Other