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

Model Number	EN
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Visual Impairment (2138); Vitritis (2181); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day post-implantation of an intraocular lens (iol) into the right eye (od), inflammation, some fibrin, hypopyon and vitritis was observed.The surgeons stated based on findings it was likely toxic anterior segment syndrome (tass) but could not rule out endophthalmitis.A tap culture was performed, and an injection of vancomycin/ceftazidime was administered.The results of the culture were negative.Residual vitritis and anterior chamber (ac) cell are slowly resolving.Patient outcome is good.In the surgeon's opinion, the most likely cause of the event is the iol.The following medications were prescribed for use at home postoperatively: prednisolone 1% 1 drop every hour, moxifloxacin 0.5% 1 drop 4 times a day, pred-moxi-bromfenac 1 drop 3 times a day.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.
Additional Manufacturer Narrative
Additional info: d4, g3, h2, h4.Correction: h6.
Event or Problem Description
Additional information was received indicating the toxic anterior segment syndrome/inflammation resolved after treatment.The patient's most recent uncorrected distance visual acuity (ucdva) was 20/20.
Additional Manufacturer Narrative
Additional information: b5, g3, h2, h6, h11.Correction: h6.

• 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 place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21766984
• Report Number: 0001313525-2025-00037
• Device Sequence Number: 21035642
• Product Code: MFK
• UDI-Device Identifier: 10757770637154
• UDI-Public: (01)10757770637154(17)270930(11)241015(10)3Q26679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2025

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: ENU1450
• Device Lot Number: 3Q26679
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/30/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96594
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON DISCOVISC, ALCON BSS, B+L INJECTOR SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female