MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT SQUARE EDGE IOL; INTRAOCULAR LENS

Model Number	LI61SE
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during implantation of an intraocular lens (iol) into the left eye, there was capsular failure.The incision was enlarged to allow for removal of the iol, a backup lens was implanted, and a suture was used to close wound.Patient prognosis is good.In the surgeon's opinion, the most likely cause of the event is a defective lens.Additional information was requested, but not received.
Additional Manufacturer Narrative
The device was returned for evaluation.Microscopic examination was performed and found the lens with a haptic slightly bent in the loop area.The product evaluation could not verify the failure mode due to the condition in which it was returned.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 SQUARE EDGE IOL
• Common Device Name: 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 ; 7277246600
• MDR Report Key: 18181368
• Report Number: 0001313525-2023-70126
• Device Sequence Number: 7717499
• Product Code: HQL
• UDI-Device Identifier: 10757770229786
• UDI-Public: (01)10757770229786(17)270131
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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 Model Number: LI61SE
• Device Catalogue Number: LI61SE1600
• Device Lot Number: 4243401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown