MAUDE Adverse Event Report: Bausch + Lomb enVista Envy hydrophobic acrylic intraocular lens; Lens, multifocal intraocular

Model Number	EN
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) in the right eye (od), the refractive outcome revealed an approximately 3.0 diopter refractive miss.The iol power calculations were reviewed and confirmed to be accurate, indicating that the patient should have achieved the intended refractive outcome.Based on these findings, the surgeon suspected that the implanted iol may have been mislabeled and elected to perform an iol exchange using the same model and diopter power approximately 6 weeks after the initial procedure.Patient outcome is good.In the surgeon's opinion, the most likely cause of the event is the initial iol was mislabeled.
Additional Manufacturer Narrative
The lens was returned and evaluated.The original packaging and labeling were not received.The lens was received in two pieces, with a haptic attached to each piece.Power verification testing determined that the measured lens power did not correspond to the power designated for the serial number.Based on the available information, device manufacturing may have contributed to the event.Corrective measures have been initiated to mitigate future similar occurrences.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.

• Brand Name: enVista Envy hydrophobic acrylic intraocular lens
• Common Device Name: Lens, multifocal intraocular
• Manufacturer (Section D): Bausch + Lomb; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): Bausch + Lomb; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 50376656
• Report Number: 0001313525-2026-00123
• Device Sequence Number: 5663058
• Product Code: MFK
• UDI-Device Identifier: 10757770637178
• UDI-Public: (01)10757770637178(17)281231(11)260106(10)3R34930
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: EN
• Device Catalogue Number: ENU1550
• Device Lot Number: 3R34930
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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 Age: 73 YR
• Patient Sex: Female