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

Model Number	IC8APT+175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Diplopia/Double Vision (4802)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Additional information was requested, but not received.As the lot number was not provided, the udi-pi is not available and the associated device history record was not reviewed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information the root cause of this event could not be determined.
Event or Problem Description
It was reported that approximately two months after intraocular lens (iol) implantation into the left eye, the patient complained of persistent image ghosting and monocular diplopia.A successful lens exchange was performed using a non-bausch + lomb iol and the symptoms resolved.The patient's outcome is good.In the surgeon¿s opinion, the likely cause of the event was intolerance to a small aperture iol.

• 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): ACUFOCUS, INC., A BAUSCH + LOMB COMPANY; 21 n. park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 20472111
• Report Number: 0001313525-2024-00162
• Device Sequence Number: 12663302
• Product Code: POE
• UDI-Device Identifier: 00813359020885
• UDI-Public: (01)00813359020885
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P210005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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 Model Number: IC8APT+175
• Device Catalogue Number: 82078-175
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: DUOVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown