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

Model Number EZ-24

Device Problems Mechanical Problem (1384); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The inserter was not returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review 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.Based on the information provided, a definitive root cause cannot be determined.No corrective action is necessary at this time.

Event Description

It was reported that during insertion of an intraocular lens (iol) there was a loading error which kinked.The lens was removed intraoperatively by cutting the lens in half and enlarging the incision to 2.8mm for lens removal.Sutures were required.The iol damage was noticed intraoperatively during lens insertion.The lens was replaced with a lens of the same model and diopter.In the physician's opinion the most likely cause of the iol damage was loading error.The surgical procedure was phaco only.The patient did not notice a decrease in their vision.The patient's current prognosis is good.The products were discarded and are not available for analysis.

• Brand Name: EASY-LOAD LENS DELIVERY SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 10317177
• MDR Text Key: 200243641
• Report Number: 0001313525-2020-00096
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K132481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,06/26/2020

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-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 06/26/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 74 YR