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

Model Number	ETN
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.
Event or Problem Description
It was reported that 1-day after implantation of an intraocular lens (iol) into the left eye, the patient presented with an unusual amount of post-op cell described as mild cell, but larger than normal on day 1.The patient's best correct visual acuity (bcva) decreased from 20/25 pre-op to 20/60 at 1-week post-op, remaining the same 1-month post-op.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Approximately 11 weeks after implantation, a vitrectomy was performed for vitreous opacities that had developed post-op.In the surgeon's opinion, the most likely cause of the event is that the lens caused mild tass.Patient outcome is good.The following medications were prescribed for use at home post-operatively: pred/moxi/brom gtt qid 1 week/tid 1 week/bid 1 week.

• 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: 22467316
• Report Number: 0001313525-2025-00142
• Device Sequence Number: 12738833
• Product Code: MFK
• UDI-Device Identifier: 10757770643087
• UDI-Public: (01)10757770643087(17)271031(11)241127(10)3Q32439
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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+175
• Device Lot Number: 3Q32439
• 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: 06/22/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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: STABLEVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male