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

Model Number EZ-28V

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

Patient Problem No Code Available (3191)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

As per the reporter, the device has been discarded and is not available for analysis.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.There have been no other complaints for this lot to date.The 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.No additional investigation or corrective action is necessary at this time.

Event Description

It was reported that the trailing haptic was damaged/bent on insertion causing the lens to be unusable.The surgical time was extended and the incision enlarged to remove the intraocular lens (iol).Sutures were not required, and no other patient injury was reported.Additional information has been requested and not received.

Manufacturer Narrative

Additional information received indicated that the incision enlargement reported in this case falls within the standard range for the inserter used to implant the backup lens.Therefore, based on the additional information provided, this event no longer meets reportability requirements.

• 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
• MDR Report Key: 11207186
• MDR Text Key: 227930475
• Report Number: 0001313525-2021-00014
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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 Expiration Date: 07/27/2021
• Device Model Number: EZ-28V
• Device Lot Number: H060401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT SQUARE EDGE IOL; SOFPORT SQUARE EDGE IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR