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

Model Number	IC8APT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of this event is still ongoing.A follow-up report will be provided upon conclusion of the investigation.
Event or Problem Description
It was reported that after the implantation of an intraocular lens (iol), the patient complained of poor visual acuity and headaches.Approximately 3 months post-implantation of the initial iol, the lens was removed and replaced with a different model iol.Additional information was requested, but not received.
Additional Manufacturer Narrative
The lens was returned and evaluated.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.Based on the available information, the root cause of this event could not be conclusively determined.

• Brand Name: IC-8 APTHERA IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman street; rochester NY 14609
• Manufacturer (Section G): ACUFOCUS, INC A BAUSCH + LOMB COMPANY; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 18870935
• Report Number: 0001313525-2024-70066
• Device Sequence Number: 20816909
• Product Code: POE
• UDI-Device Identifier: 00813359020984
• UDI-Public: (01)00813359020984(17)260223(11)230224(10)BE-GA-23012
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P210005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 02/23/2026
• Device Model Number: IC8APT
• Device Catalogue Number: IC8APT+225
• Device Lot Number: BE-GA-23012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown