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)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
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 successfully exchanged for a different power lens.Additional information was requested but not received.This is event #1 of 2.Ref#0001313525-2026-00003.
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 were 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
Additional information was received indicating that the superior-temporal decentration and mild phimosis was observed approximately two weeks after implantation of the iol in the patient's left eye (os).The iol exchange was performed approximately two weeks after the onset of problem.Approximately one-week post-exchange, a yag laser capsulotomy was performed.After this intervention, the iol was noted to be well centered, although there is still mild phimosis.According to the surgeon, the most likely cause of the event was a chronic inflammatory stimulus from the lens.
Additional Manufacturer Narrative
Additional information: a2, a3a, b3, b5, b6, d1, d4, d6a, d9, g3, h2, h3, h4, h6 & h11.Product evaluation found the lens in one piece with both haptics attached.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.

• 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: 24094966
• Report Number: 0001313525-2026-00002
• Device Sequence Number: 10468738
• Product Code: MFK
• UDI-Device Identifier: 10757770643070
• UDI-Public: (01)10757770643070(17)271231(11)250128(10)3R02121
• 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: ETNU300+170
• Device Lot Number: 3R02121
• 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: 01/28/2025
• 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: 58 YR
• Patient Sex: Male