MAUDE Adverse Event Report: BAUSCH + LOMB EASY-LOAD LENS DELIVERY SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number EZ-28V

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The product evaluation has been completed.One ez-28v delivery device was returned inside of a plastic zip-lock bag inside of a lens box.The original device packaging was not returned.The lot number of the returned device cannot be verified or determined.Visual inspection found the tip to be bent.In addition, the tip is split on the bottom side through the center of the flat bottom and over to the side of the tip.A small amount of dried solution was visible in the tip and loading deck area.Functional testing cannot be performed due to the condition of the returned device.The product evaluation could not determine the cause of the damage.Further investigation is in progress.A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported that while inserting an intraocular lens (iol), the inserter tip cracked and the iol became stuck in the inserter.The lens was halfway in patient¿s eye, and the surgeon removed the lens intraoperatively.The intraoperative lens removal did not require incision enlargement or sutures.There was no injury to the patient.A backup lens of the same model and diopter was successfully implanted.

Manufacturer Narrative

The product evaluation confirmed the failure mode.Splitting can occur in cases of incorrect delivery or errors during delivery.For example, if the plunger bypasses the lens and rides on top of the lens during the delivery, it will add bulk to the lens and could potentially cause splitting.Based on the evaluation of the returned device and the investigation, the inserter was most likely split during delivery due to user error.A review of nonconformances (ncs) for the previous twelve months was performed.There were no ncs that would contribute to the reported event.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.The most probable root cause is operational context.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.No additional investigation or corrective action is necessary at this time.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 10605970
• MDR Text Key: 209155655
• Report Number: 0001313525-2020-00145
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ-28V
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT INTRAOCULAR LENS (IOL) LI61SE; SOFPORT INTRAOCULAR LENS (IOL) LI61SE