MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS INTRAOCULAR LENS

Model Number	AO60
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned and evaluated.Examination found the lens cut in 2 pieces across the optic.No other defects on the lens were observed.A device history record (dhr) review, lot history, trend analysis, risk analysis and/or directions for use review are underway.
Event or Problem Description
It was reported that approximately two months after implantation of an intraocular lens (iol) into the right eye (od), the lens was exchanged for a different model iol due to mechanical breakdown of the initial lens.Additional information was requested but not received.
Additional Manufacturer Narrative
A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Additional information: d4, g3, g6, h2, h4, h6, h11.

• Brand Name: AKREOS INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 21 north park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22077479
• Report Number: 0001313525-2025-00112
• Device Sequence Number: 21175777
• Product Code: HQL
• UDI-Device Identifier: 10757770502056
• UDI-Public: (01)10757770502056(17)270731(11)240809(10)1Q21712
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: AO60
• Device Catalogue Number: AO60P2000
• Device Lot Number: 1Q21712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male