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 Corneal Touch (1794)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, the most probable cause is user related.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.On (b)(6) 2021, bausch + lomb received an email from (b)(6) at cdrh/food and drug administration notifying the company that the report initially submitted on (b)(6) 2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

A healthcare facility in (b)(6) reported that while implanting an intraocular lens (iol) that the lens exited the injector with the front haptic partially ripped from the optic.The partially ripped haptic was bent in the direction of the endothelium resulting in endothelium-touch.It is reported that the lens was prepared with viscoelastic and placed in the injector as per usual process.The surgery nurse advised that it was difficult to put the iol into the injector as at the first attempt the lens-bracket could not be clipped.As the healthcare facility did not have the appropriate equipment for the removal and replacement of the iol this was performed the same day at a different hospital.Additional information has been requested.

Manufacturer Narrative

The delivery device was received for evaluation.Visual inspection found that the tip of the delivery device was bent and a small amount of dried solution was visible in the loading deck and tip.Due to the condition of the product functional testing could not be performed.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, the most probable cause is user related.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.

• 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: 11574501
• MDR Text Key: 252700419
• Report Number: 0001313525-2021-00037
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 05/18/2021
• Device Model Number: EZ-28V
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT IOL, AMVISC
• Patient Outcome(s): Required Intervention