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

Model Number LI61AO

Device Problem Unintended Movement (3026)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported during implantation of an intraocular lens (iol) into the right eye, the posterior capsule ruptured causing the lens to be unstable.The incision was enlarged to allow for removal of the iol and a suture was placed as standard protocol.Approximately ten days after explant, a vitrectomy was performed and a lens of the same model, same diopter was implanted.Patient outcome is good.

Manufacturer Narrative

The device was returned for evaluation.Microscopic examination found the lens with no visible defects.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 of this 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 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17702006
• MDR Text Key: 322879368
• Report Number: 0001313525-2023-70107
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 10757770474285
• UDI-Public: (01)10757770474285(17)280430
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: LI61AOR1850
• Device Lot Number: 42310432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• 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: EZ-28V INJECTOR, AMVISC, VISCOAT, ALCON BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR