MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ASPIRE IOL; INTRAOCULAR LENS

Model Number	EA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during insertion of an intraocular lens (iol) into the right eye (od) the capsule ruptured, and the iol dropped through the defect in the capsular bag.The iol was removed, a vitrectomy was performed, and a different model iol was implanted into the sulcus.In the surgeon's opinion, the most likely cause of the event was the iol dropped through capsular defect.The patient's outcome is good.
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.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; however, it is noteworthy to mention an unvalidated injector was used to complete the original implant.

• Brand Name: ENVISTA ASPIRE 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: 23360956
• Report Number: 0001313525-2025-00195
• Device Sequence Number: 18414664
• Product Code: HQL
• UDI-Device Identifier: 10757770608581
• UDI-Public: (01)10757770608581(17)280331(11)250428(10)3R10941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2025

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: EA
• Device Catalogue Number: EAU2150
• Device Lot Number: 3R10941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALCON MONARCH III INJECTOR AND CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female