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

Model Number	LI61AO
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.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, 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
Reportedly, during the intraocular lens (iol) implant procedure the iol haptic became stuck in the injector, and it was unable to eject.Surgeon was unable to proceed without an iol, therefore, patient was left aphakic.Additional information has been requested but not yet received.This report reflects lens 1 of 3.Reference report numbers: 0001313525-2024-00120 and 0001313525-2024-00121.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19787558
• Report Number: 0001313525-2024-00119
• Device Sequence Number: 8429196
• Product Code: HQL
• UDI-Device Identifier: 10757770474346
• UDI-Public: (01)10757770474346(17)281031
• Combination Product (Y/N): N
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: LI61AOR2150
• Device Lot Number: 4P28511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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 Sex: Unknown