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

Model Number	IC8APT+255
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3.5 months after implantation of an intraocular lens (iol) in the left eye (os), the patient complained of dissatisfaction with visual clarity, describing halos and a sensation of looking through "dirty glass".Approximately 6 months after symptom onset, an optometrist observed a divot in the superior/temporal portion of the filter ring of the iol's optic.Approximately one year later, the initial iol was removed and a replaced with a different model lens positioned in the sulcus.In the surgeon's opinion, the most likely cause of the event was the patient's inability to adapt to the unique optics of the iol and experienced subjective visual disturbances.Patient outcome is good.
Additional Manufacturer Narrative
The device was returned and evaluated.The device was received in 2 pieces, each with an attached haptic.One of the returned pieces exhibited a jagged outer edge on the optic with material missing.The reported iol defect was not confirmed.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/or 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.

• 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25084818
• Report Number: 0001313525-2026-00044
• Device Sequence Number: 10433973
• Product Code: POE
• UDI-Device Identifier: 00813359021042
• UDI-Public: (01)00813359021042(17)280104(11)240105(10)BE-GA-24001
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2026
• 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
• Report Date (Section B): 05/05/2026

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+255
• Device Catalogue Number: 82078-255
• Device Lot Number: BE-GA-24001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOLI-A1 INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female