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

Model Number	BLIS-X1
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore not available for evaluation.Additional information regarding the event was requested, but not received.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, the root cause of this event could not be conclusively determined.
Event or Problem Description
It was reported that upon delivery of an intraocular lens (iol) into the eye, the surgeon noticed the haptic was damaged.Under microscopic examination, the surgeon discovered the very tip of trailing haptic was missing and not in the eye, it was in the injector cartridge.The incision was enlarged to allow for removal of the iol and a successful intraoperative lens exchange was performed using a backup iol of the same model and diopter.Patient outcome is good.Additional information was requested, but not received.
Additional Manufacturer Narrative
Additional information: a2, a3a, b5, b6, g3, h2, h11.
Event or Problem Description
Additional information was received indicating the original implant was in the right eye.In the surgeon's opinion, the most likely cause of the iol damage is from the lens sticking in delivery device.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Common Device Name: 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 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19392467
• Report Number: 0001313525-2024-00105
• Device Sequence Number: 12703145
• Product Code: MSS
• UDI-Device Identifier: 00757770520183
• UDI-Public: (01)00757770520183
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K131958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: BLIS-X1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female