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

Model Number	LI61AO
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Corneal Scar (1793); Visual Impairment (2138); Eye Pain (4467)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, device was discarded and is not available for evaluation.A device history record (dhr) review did not find any non-conformities or anomalies related to this event.The trend analysis, risk analysis and/or 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 caused or contributed to this event.
Event or Problem Description
Reportedly, after implantation of an intraocular lens (iol) into the left eye it was discovered that iol haptics were bent.The surgeon attempted to straighten the haptics and during the process the iol flipped over and scratched the cornea.On post-op visit it was discovered that lens had shifted causing pain and visual problems for the patient.The lens was explanted 3 days post implant due to lens dislocation and extruded lens in the anterior chamber.A vitrectomy was performed, and the lens was replaced with another iol of the same model and diopter.
Event or Problem Description
Additional information was received indicating the patient had a capsule rupture that occurred during cataract emulsification prior to the iol being placed.Therefore the lens was implanted in the sulcus.In the surgeons opinion the likely cause of this event is the kinked haptic in two locations leading to lens instability and subsequent dislocation in the anterior chamber.
Additional Manufacturer Narrative
G4: added udi.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 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: 16042553
• Report Number: 0001313525-2022-00190
• Device Sequence Number: 4897067
• Product Code: HQL
• UDI-Device Identifier: 10757770474216
• UDI-Public: (01)10757770474216(17)250131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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: 01/31/2025
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR1500
• Device Lot Number: 4041711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 03/08/2023; 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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: EASY LOAD INJECTOR.PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male