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 Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Per the reporter, the device has been discarded and is not available for evaluation.The investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

Reportedly, trailing haptic was noticed bent, after loading the iol into the right eye.The capsular bag was reported broken and there was vitreous loss.The lens was then removed and a vitrectomy was performed.The patient was left aphakic due to the cornea being too cloudy.According to the surgeon, patient outcome will be good as long as corneal edema clears and a backup iol is implanted at a later date.In the physician¿s opinion, the most likely cause of this event is a loading error.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Although requested, a lot number was not provided; therefore, a device history record (dhr) review could not be performed.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined; however, user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or 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 goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15349267
• MDR Text Key: 299178345
• Report Number: 0001313525-2022-00112
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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-28V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2022
• 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
• Treatment: SOFPORT LI61AOR IOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male