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

Model Number	ETN
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Contracture (1761); Inflammation (1932); Blurred Vision (2137); Halo (2227); Zonular Dehiscence (2698)
Date of Event	09/18/2025
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.As a serial number for the device was not provided, the associated device history record was not reviewed.The 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, a root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol), the surgeon noted superior decentration of the iol and capsular phimosis during slit lamp examination.The iol was exchanged for a different power lens.Additional information was requested but not received.This is event #2 of 2.Ref# 0001313525-2026-00002.
Additional Manufacturer Narrative
Additional information: a1, a2, a3a, b3, b5, b6, b7, d1, d4, d6a, d6b, d9, g3, h2, h3, h4, h6 & h11.Product examination found the lens in one piece with both haptics attached.One haptic was noted to be bent, and a scratch at haptic-optic junction was observed.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the information provided, a root cause of this event could not be determined.
Event or Problem Description
This event was originally reported as event #2 for patient identifier (a)(1) (b)(6).Since patient identifiers were later provided, the case has been reassigned to patient identifier (a)(1) (b)(6).Additional information was received indicating six months after implantation of the iol in the patient's left eye (os), the patient reported that vision was no longer as crisp as three months prior.Examination at that time identified inferior decentration of the iol and phimosis of the anterior capsule.Nine months post-implantation, during the lens exchange, a capsular tension ring was implanted due to zonular dehiscence.According to the surgeon, the most likely cause of the event was a chronic inflammatory stimulus from the lens.Following the exchange, the surgeon discussed with the patient the options of prk or lasik to enhance distance vision.The patient continues to report seeing halos, which the surgeon attributes to the patient's inability to adapt to the lens design.

• Brand Name: ENVISTA ENVY TORIC 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 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 24095015
• Report Number: 0001313525-2026-00003
• Device Sequence Number: 13336158
• Product Code: MFK
• UDI-Device Identifier: 10757770642042
• UDI-Public: (01)10757770642042(17)270731(11)240830(10)3Q23432
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: ETN
• Device Catalogue Number: ETNU250+225
• Device Lot Number: 3Q23432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female