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

Model Number	IC8APT+165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, 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 could not be conclusively determined.
Event or Problem Description
It was reported that approximately 16 weeks after implantation of an intraocular lens (iol), the iol was exchanged with a different model iol due to unresolved symptoms of glare and pinwheel around lights at night.In the surgeon''s opinion, the most likely cause of event is that somehow light was able to pass around the outside of the pinhole inlay leading to severe glare symptoms at night.Patient outcome is good.Additional information was requested, but not received.
Event or Problem Description
Additional information was received indicating the intended target for ic-8 iol was -1.00.
Additional Manufacturer Narrative
Based on additional information received, indicating off-label use of the device, the device causality is unrelated and therefore, 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): ACUFOCUS, INC., A BAUSCH + LOMB COMPANY; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 18922017
• Report Number: 0001313525-2024-00073
• Device Sequence Number: 6189050
• Product Code: POE
• UDI-Device Identifier: 00813359020861
• UDI-Public: (01)00813359020861(17)260411(11)230412(10)BE-GA-23020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 04/11/2026
• Device Model Number: IC8APT+165
• Device Catalogue Number: 82078-165
• Device Lot Number: BE-GA-23020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: No
• 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: 03/18/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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: PROVISC,VISCOAT,VIGAMOX,LIDOCAINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male