MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon implantation of an intraocular lens (iol) in the eye, the surgeon observed a crack at the optic-haptic junction.The incision was enlarged, the damaged iol was removed, and a replacement lens was implanted.According to the surgeon, the patient experienced significant postoperative corneal edema, which was attributed to the extended surgical time and additional tissue manipulation required for lens removal and replacement.In the surgeon's opinion, the most like cause of the event was the lens itself, noting that the technician did not notice any issues during lens loading.Additional information was requested but not received.
Additional Manufacturer Narrative
Although requested, the device is not available for evaluation and additional information regarding the event was not provided.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/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause could not be conclusively determined.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 n park pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 25553427
• Report Number: 0001313525-2026-00086
• Device Sequence Number: 18828014
• Product Code: HQL
• UDI-Device Identifier: 10757770607843
• UDI-Public: (01)10757770607843(17)280930(11)251022(10)3R28350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: EE
• Device Catalogue Number: EEU1850
• Device Lot Number: 3R28350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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: PROVISC, VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown