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

Model Number LI61AOR

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Disturbances (2140); Eye Pain (4467)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

A consumer reported pain and light sensitivity one day post lens implant.It was reported that the haptic of an intraocular lens (iol) was damaged upon implantation in the left eye.The surgeon attempted to remove the iol from the patient¿s eye with no success.Approximately six days post implantation the iol was reportedly dislodged, and within the fundus.The patient was referred to a retina specialist who then performed a vitrectomy and removed the iol two weeks post implant.An iol of a different model and diopter was placed in the left eye sulcus.The patient reportedly has a great outcome and vision.Additional information has been requested.

Manufacturer Narrative

The device was not returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information, user related factors (such as loading and handling issues, and/or procedural factors such as lens and inserter interaction) may have caused or contributed to this event.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: 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
• MDR Report Key: 13357651
• MDR Text Key: 284446282
• Report Number: 0001313525-2022-00009
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LI61AOR
• Device Catalogue Number: LI61AOR2150
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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 LENS DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male