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

Model Number EZ-24

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

Patient Problem Vitreous Loss (2142)

Event Date 05/24/2023

Event Type  Injury  

Event Description

It was reported that while performing a combined intraocular lens (iol) exchange and vitrectomy procedure, during implantation of the iol into the left eye, it was observed that the leading haptic was bent beyond repair.The iol was removed.Small zonular dialysis was observed with vitreous loss.A vitrectomy was performed, and a successful lens exchange was performed positioning a backup three-piece lens in the ciliary sulcus.In the surgeon's opinion, the most likely cause of the iol damage was the delivery device which allegedly led to the bent haptic.Patient outcome is good.Additional information was requested, but not received.

Manufacturer Narrative

Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.As a device lot number was not provided, a review of the device history record (dhr) could not be performed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, 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.

Manufacturer Narrative

Corrected data: g3, e1.

• 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 (Section G): BAUSCH + LOMB; 21 n park pl blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17184871
• MDR Text Key: 317726469
• Report Number: 0001313525-2023-70075
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770529032
• UDI-Public: (01)00757770529032
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2023
• 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: SILICONE IOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male