MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB IOL INJECTOR; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number INJ100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Additional information was requested but not received.As a lot number was not provided a device history record review (dhr) 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 determined.

Event Description

It was reported that during a cataract surgery the intraocular lens was stuck in the injector.The injector was removed from the eye, the iol was removed from the injector and transferred to another injector of a different model.During the implantation with the replacement injector a ruptured posterior capsule was observed.An anterior vitrectomy was performed to remove the vitreous.The main incision was enlarged before the iol implantation.The lens remains implanted in the eye and a follow-up appointment is planned to check that the lens is in the correct position.Although requested additional information was not obtained.

• Brand Name: BAUSCH + LOMB IOL INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19123075
• MDR Text Key: 340337478
• Report Number: 0001313525-2024-00084
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K113852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

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: INJ100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2024
• 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: ENVISTA IOL, VISCOJECT BIO 2.2
• Patient Outcome(s): Required Intervention