MAUDE Adverse Event Report: BAUSCH + LOMB INC. ENVISTA ASPIRE TORIC IOL; INTRAOCULAR LENS, TORIC

Model Number	ETA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation and additional information regarding the event was not provided.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the information provided, we are unable to determine a root cause.
Event or Problem Description
A capsular damage involving an envista iol was reported.It is unclear if the capsule damage happened during phaco, lens implant, or lens rotation.Additional information was requested but not received.

• Brand Name: ENVISTA ASPIRE TORIC IOL
• Common Device Name: INTRAOCULAR LENS, TORIC
• Manufacturer (Section D): BAUSCH + LOMB INC.; 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: 25045459
• Report Number: 0001313525-2026-00041
• Device Sequence Number: 15884401
• Product Code: HQL
• UDI-Device Identifier: 10757770621337
• UDI-Public: (01)10757770621337(17)280630(11)250807(10)3R16636
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: ETA
• Device Catalogue Number: ETA150+165
• Device Lot Number: 3R16636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown