MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB VIS100 INJECTOR SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number VIS100

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

Patient Problem Capsular Bag Tear (2639)

Event Date 12/07/2023

Event Type  Injury  

Event Description

Reportedly, there was insufficient capsular support.A vitrectomy was performed, and a lens of a different model was placed in the anterior chamber.Additional information was requested but not received.

Manufacturer Narrative

The product is not available for return and the lot number is unknown.Therefore, a device history record (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 information provided, the root cause of this event could not be conclusively determined.

• Brand Name: BAUSCH + LOMB VIS100 INJECTOR SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 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: 18678755
• MDR Text Key: 335074758
• Report Number: 0001313525-2024-70036
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2023

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: VIS100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• 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: AMVISC, AKREOS ADVANCED OPTICS IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male