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 11/02/2016

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 while loading and advancing the lens during preparation for use, the injector tip split and the lens came out of the side of the injector.The surgeon re-loaded the lens into another injector and successfully completed the case without issues.

Manufacturer Narrative

Evaluation of the returned device did not find any evidence of the tip being split or torn on the sides.The reported issue (split tip) was not confirmed.However, the tip was bent was bent and the lens was found stuck in the delivery device tip with both haptics bent.The plunger rod was found to be advanced passed the lens up into the 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 may have caused or contributed to the reported issue.

• 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: 6139289
• MDR Text Key: 61304591
• Report Number: 0001313525-2016-00712
• 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: 11/02/2016

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: 06/09/2017
• Device Model Number: EZ-28V
• Device Lot Number: H656101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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 Outcome(s): Other