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 Insufficient Information (4580)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.Investigation of this event is in progress and a follow-up report will be submitted upon completion of investigation.

Event Description

It was reported that during iol implantation one of the device haptics was cut off by the injector.The lens was cut out and replaced with an unknown model.The incision was enlarged.A stitch was required to close the wound.The patient has a follow up appointment to have their cornea repaired.In the surgeon¿s opinion faulty injector caused this event.Additional information was requested.

Manufacturer Narrative

Although requested, the device was not returned.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The lot history, 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.

Event Description

Additional information was received.The suture used for wound closure was not part of standard protocol.Reportedly, the silicone plunger (tip) expanded in the anterior chamber which made it difficult to remove the plunger out of the incision.The patient required a dsek procedure after the original procedure.Although requested, further additional information has not been received.

• Brand Name: BAUSCH + LOMB VIS100 INJECTOR 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): 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: 18386303
• MDR Text Key: 331241722
• Report Number: 0001313525-2023-70140
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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 Catalogue Number: VIS100
• Device Lot Number: 2319E7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention