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

Model Number LI61AO

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Vitreous Detachment (2445)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that intraocular lens (iol) was explanted approximately 4 months after initial implant.Reportedly, the surgery required an unplanned pars plana vitrectomy due to vitreous prolapse of subluxed lens.A 3.2 mm incision was made to remove the iol, but the vitreous prolapse strands were obstructing safe lens removal; therefore, a second incision of 2.5 mm was created.At this time, another lens was successfully implanted using same model lens with different diopter.Sutures were used on both sites.Patient is doing well.

Manufacturer Narrative

Device was returned and evaluated.Visual inspection found the lens cut or torn in two pieces.Haptics were attached to each piece of the lens.Both haptics were bent.The cause of the damage could not be determined.Due to the damage, diopter and functional testing could not be performed.Investigation of this event is in progress.A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of the reported event could not be conclusively determined.

• 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: 13283167
• MDR Text Key: 283967255
• Report Number: 0001313525-2022-00006
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR1250
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention