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

Model Number EZ-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Disturbances (2140); Vitrectomy (2643)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the lens dislocated after it was implanted in the patient¿s right eye.During the surgery to re-position the lens, it was noticed that the trailing haptic had broken off in the bag and the leading haptic was sitting on the retina.The lens was explanted and a vitrectomy was performed.An ac iol was then implanted.The incision was enlarged to remove the lens and sutures were needed.The physician believed the haptic likely broke off during the original implant procedure.The patient was doing well post lens exchange.

Manufacturer Narrative

The delivery device was not returned to bausch + lomb; therefore, a product evaluation could not be performed.The lot number was not provided; therefore, a device history record (dhr) review could not be performed.Based on available information, a root cause for the reported event could not be conclusively determined.

• Brand Name: M-PORT SI INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8332992
• MDR Text Key: 135943304
• Report Number: 0001313525-2019-00031
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K970727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EZ-28
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT AO INTRAOCULAR LENS.; SOFPORT AO INTRAOCULAR LENS.
• Patient Outcome(s): Other
• Patient Age: 60 YR