MAUDE Adverse Event Report: BAUSCH + LOMB IC-8 APTHERA IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	IC8APT+240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the eye, the lens was explanted.Additional information was requested but not received.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.A review of the device history record (dhr) did not identify any anomalies or non-conformities that could be related to this event.The lot history, risk analysis, and directions for use review were 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
Additional information was received with the surgeon indicating no issues with the iol.Lens exchange was performed two weeks after the original implant due to vision issues such as not seeing well, very dim and looking through a keyhole.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h11.Based on additional information received this event no longer meets reportability requirements and is no longer deemed reportable.

• Brand Name: IC-8 APTHERA IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22841449
• Report Number: 0001313525-2025-00167
• Device Sequence Number: 9580605
• Product Code: POE
• UDI-Device Identifier: 00813359021011
• UDI-Public: (01)00813359021011(17)280625(11)240626(10)BE-GA-24047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P210005
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: IC8APT+240
• Device Catalogue Number: 82078-240
• Device Lot Number: BE-GA-24047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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 Sex: Unknown