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

Model Number	IC8APT+190
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implantation of an intraocular lens (iol) into the right eye (od), the iol trailing haptic was allegedly stuck in the injector.The following day, the surgeon observed that the iol was decentered.Approximately, 2 weeks later, an iol exchange was performed, and it was noted that there was a broken haptic on the initial iol.In the surgeon¿s opinion, the most likely cause of the event is the broken haptic.Patient outcome is good.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Additional info: d4, d9, g3, h2, h3, h4, h6, h11.The device was returned and evaluated.Examination was performed and found the lens in 2 pieces with one haptic broken and the piece of the broken haptic missing.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, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

• 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: 23323417
• Report Number: 0001313525-2025-00192
• Device Sequence Number: 21485778
• Product Code: POE
• UDI-Device Identifier: 00813359020915
• UDI-Public: (01)00813359020915(17)280104(11)240105(10)BE-GA-24001
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P210005
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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+190
• Device Catalogue Number: 82078-190
• Device Lot Number: BE-GA-24001
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIOLI-A1 INJECTOR, CLEARVISC, AND AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown