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

Model Number	LI61AO
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested, but not received.The device was returned for evaluation.Visual inspection found no damage or visible defects.A review of the device history record (dhr), did not find any anomalies or nonconformities that may have contributed to the reported event.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information provided, a root cause could not be conclusively determined.
Event or Problem Description
It was reported that approximately 11 years after implantation of an intraocular lens (iol) into the right eye, the iol dislocated and an uncomplicated lens exchange was performed using a different model iol.Additional information was requested, but not received.

• 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 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21397427
• Report Number: 0001313525-2025-00014
• Device Sequence Number: 9199582
• Product Code: HQL
• UDI-Device Identifier: 10757770474186
• UDI-Public: (01)10757770474186(17)180430
• 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
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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): 01/21/2025

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 Expiration Date: 04/30/2018
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR1350
• Device Lot Number: 4352112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2013
• 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 VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male