MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS SINGLE USE INSERTION DEVICE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	AI-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned and additional information regarding the event was not provided.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis and direction for use review were considered acceptable, with the product performing with anticipated rates.Based on the available information, the root cause could not be conclusively determined.
Event or Problem Description
Reportedly, after implantation of an iol two large cracks were observed across the center.The iol was removed extending the surgery time.A replacement lens was implanted successfully.Additional information was requested, but not received.
Event or Problem Description
Additional information received.When the iol was removed, a posterior capsule tear occurred.The patient required further treatment within the same procedure.

• Brand Name: AKREOS SINGLE USE INSERTION DEVICE
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 727724-6600
• MDR Report Key: 21231400
• Report Number: 0001313525-2025-00007
• Device Sequence Number: 12912271
• Product Code: MSS
• UDI-Device Identifier: 00757770473946
• UDI-Public: (01)00757770473946(17)250607(11)240607(10)H2415801
• Combination Product (Y/N): N
• PMA/510(K) Number: K063694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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 Expiration Date: 06/07/2025
• Device Model Number: AI-28
• Device Lot Number: H2415801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: OCUCOAT, AMVISC, AKREOS IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown