MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	EN
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Inflammation (1932); Zonular Dehiscence (2698); Posterior Capsule Opacification (4807)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately six weeks after implantation of an intraocular lens (iol) into the right eye (od), the patient presented with a mild central capsular wrinkle and capsular contraction was noted at the 5'clock position.The patient's best corrected visual acuity (bcva) did not decrease.Approximately three months post-implantation, the surgeon planned to exchange the iol.However, when attempting to explant the lens, excessive scar tissue around the iol and zonular weakness were encountered.The surgeon elected not to remove the lens and left the iol in place.The surgeon plans to re-evaluate the patient in one month before proceeding with yag laser capsulotomy treatment.In the surgeon's opinion, the most likely cause of the event is the lens shifting posteriorly secondary to postoperative inflammation.The following medications were prescribed for use at home post-operatively: pred 1% od bid, then taper moxifloxacin 0.5% 1gtt qid ou x 1 week prolensa 0.07% 1gtt qd x 4 weeks.
Additional Manufacturer Narrative
The device remains implanted.Based on the information provided, a root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.

• 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 pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 23882226
• Report Number: 0001313525-2025-00235
• Device Sequence Number: 13167401
• Product Code: MFK
• UDI-Device Identifier: 10757770637246
• UDI-Public: (01)10757770637246(17)270430(11)240511(10)3Q11624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: EN
• Device Catalogue Number: ENU1900
• Device Lot Number: 3Q11624
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2024
• 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: AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male