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

Model Number	LI61AO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated.Microscopic evaluation found one haptic bent.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, 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 may have contributed to the event.
Event or Problem Description
A surgical center reported that during the implantation of an intraocular lens (iol) into the patients left eye a capsular tear occurred upon ejection of the lens.When the iol was inserted into the eye, the doctor noticed the leading haptic was over the optic.As he tried to fix the lens, a tear was created in the capsular bag.The lens was explanted, an anterior vitrectomy was performed, and a backup lens was successfully placed.Per the report the patient is expected to make a full visual recovery.

• 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: 22145269
• Report Number: 0001313525-2025-00120
• Device Sequence Number: 8526520
• Product Code: HQL
• UDI-Device Identifier: 10757770474322
• UDI-Public: (01)10757770474322(17)290831(11)240917(10)4Q22605
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: LI61AOR2050
• Device Lot Number: 4Q22605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: EZ-24 INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female