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

Model Number	ETN
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Visual Impairment (2138); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.Investigation of this event is in progress.Recall of device is underway.
Event or Problem Description
It was reported that approximately 3 weeks after implantation of an intraocular lens (iol) into the right eye, the patient presented with inflammation.Slit lamp findings were 1+ cell in a/c and trace flare.Patient's bcva dropped from 20/25 to 20/30.Patient has had persistent inflammation, eye pain and hazy vision since.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).The patient was treated with imprism.Five months and one week after implantation, the iol was explanted and another model multifocal iol was implanted.The patient's current outcome is unknown.
Additional Manufacturer Narrative
Updated b5, g3, h2 and h6.
Event or Problem Description
The explanting doctor reported that the tass resolved after treatment.The patient's outcome was fluctuation vision and refraction, likely surface related.M/r: -1.50+1.00x130, ucdva: 20/70-1, bcdva: 20/40- s.(b)(6) 2025.

• 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 n park place blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21896496
• Report Number: 0001313525-2025-00086
• Device Sequence Number: 3442907
• Product Code: MFK
• UDI-Device Identifier: 10757770640840
• UDI-Public: (01)10757770640840(17)270930(11)241016(10)3Q27223
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: ETNU150+195
• Device Lot Number: 3Q27223
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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: HEALON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female