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

Model Number LI61AO

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Corneal Scar (1793); Visual Impairment (2138); Eye Pain (4467)

Event Date 11/14/2022

Event Type  Injury  

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 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 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.

Manufacturer Narrative

G4: added udi.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: 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
• MDR Text Key: 306075936
• Report Number: 0001313525-2022-00190
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 10757770474216
• UDI-Public: (01)10757770474216(17)250131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR1500
• Device Lot Number: 4041711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2023; 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EASY LOAD INJECTOR.PROVISC.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male