MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT AO INTRAOCULAR LENS

Model Number	LI61AO
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.Microscopic examination was performed and found one bent haptic.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 information provided, the root cause could not be conclusively determined; however, 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.
Event or Problem Description
It was reported that after the implantation of an intraocular lens (iol) into the left eye, a bent haptic was noticed.The incision was enlarged for the removal of the iol, a back up lens was implanted, and the wound was closed with nylon sutures.Outcome of the patient is good.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n. park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21752080
• Report Number: 0001313525-2025-00035
• Device Sequence Number: 12812102
• Product Code: HQL
• UDI-Device Identifier: 10757770474315
• UDI-Public: (01)10757770474315(17)290430
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P910061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/03/2025

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: LI61AO
• Device Catalogue Number: LI61AOR2000
• Device Lot Number: 4Q10703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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: AMVISC, EZ-28V.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female