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	Capsular Bag Tear (2639)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during phacoemulsification of the right eye (od), a capsule rupture occurred.The surgeon attempted to implant an intraocular lens (iol) into the sulcus and a bent haptic was observed.The incision was enlarged to remove the iol, a vitrectomy was performed, the patient was left aphakic, and the wound was closed with sutures.The patient is expected to return at a later date for iol implantation.In the surgeon's opinion, the most likely cause of the event is a loading error.Additional information was requested but not received.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection found the lens in two pieces with one haptic completely 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.
Additional Manufacturer Narrative
Additional info: b5, g3, h2, h6, h11.
Event or Problem Description
Additional information was received indicating the patient was referred to a retina specialist for retina surgery and intraocular lens implantation.An intraocular lens was implanted in (b)(6) 2025.

• 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 23704942
• Report Number: 0001313525-2025-00219
• Device Sequence Number: 10649979
• Product Code: HQL
• UDI-Device Identifier: 10757770474292
• UDI-Public: (01)10757770474292(17)300228
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: LI61AOR1900
• Device Lot Number: 4R01503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: EZ-28V INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male