MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADVANCED OPTICS IOL; INTRAOCULAR LENS

Model Number	AO60P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for evaluation.Microscopic examination was performed and found no visible damage.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.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.
Event or Problem 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.

• Brand Name: AKREOS ADVANCED OPTICS IOL
• Common Device Name: INTRAOCULAR LENS
• 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 ; 7277246600
• MDR Report Key: 18576330
• Report Number: 0001313525-2024-70005
• Device Sequence Number: 7922758
• Product Code: HQL
• UDI-Device Identifier: 10757770502032
• UDI-Public: (01)10757770502032(17)260130
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2026
• Device Model Number: AO60P
• Device Catalogue Number: AO60P1900
• Device Lot Number: 1P20502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male