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

Model Number	ETN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Corneal Clouding/Hazing (1878); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Loss of Vision (2139); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, the device was not returned for evaluation.If additional information becomes available, a follow-up report will be submitted.Based on the information received to-date, neither the suspected tass nor endophthalmitis diagnosis can be confirmed.
Event or Problem Description
Additional information was received indicating the pathology results of the prior fibrin removal performed by the implanting surgeon was read as fibrinous membrane with no bacterial aggregates.The patient was referred to a retina surgeon again where the iol, including the capsular bag was removed, as the membrane encased the iol.An anterior vitrectomy was performed, cultures were repeated, and the patient received another round of intravitreal antibiotics.There was no growth from the cultures.Post-explant, visual acuity was light perception (lp) and intraocular pressure was very low.The patient had an additional surgery with a prosthetic cornea so that the retina could be visualized and repair what they assessed as a retinal detachment with macula off.Once intra-op, the surgeon performing this procedure felt the retina was necrotic and there was no saving the eye and procedure was aborted.Their assessment was that this was an aggressive strep infection not a tass.The most recent visual acuity is no light perception (nlp) and the eye is phthisic.In the implanting surgeon and the retina surgeon¿s (who saw the patient day 2 post-op) opinion, the most likely cause of the event is tass, stating that the initial findings of anterior membrane inflammation with cells and fibrin, corneal edema, and a mildly inflamed eye with elevated pressures are consistent with tass.Additional information was requested.
Event or Problem Description
It was reported that 1-day after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with significant inflammation in the anterior chamber.Slit lamp findings were severe kp, 3+ cells/flare, corneal edema and haze, and a membranous fibrin reaction around the trabecular meshwork leading to an iop spike.The next day, the patient had iop of 35mmhg & visual acuity was light perception (lp).An anterior chamber (ac) rinse was performed the same day, and iop decreased to 5mmhg.The patient was referred to retina for a tap & inject.Results of the culture were negative.B-scan was negative for vitritis.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Four days post-op the wound was closed.The following day, a procedure was performed to strip membrane off of the iris and anterior chamber angle and the fibrin was sent to pathology.The surgeon stated that during this procedure, visualization was not good enough to remove the iol.In the surgeon¿s opinion, the most likely cause of the event is tass.Patient outcome is unknown.4+ cornea edema started to clear up & iop is under control.The eye remains inflamed with visual acuity of lp and there is still a membranous clot behind lens.Per the surgeon, the patient will require further procedures.The patient remains on 2 medications for iop and is being closely monitored.Additional information regarding patient outcome is anticipated.Medications prescribed for use at home post-operatively: pred q1h, brimonidine tid, timolol bid, ketorolac qid, moxifloxacin qid, tobramycin qid, and acetazolamide 500mg bid, durezol.
Additional Manufacturer Narrative
The device remains implanted.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 available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.
Additional Manufacturer Narrative
Additional information: b4, b5, b7, d6b, g3, h11.
Event or Problem Description
Additional clinical information was received indicating that approximately six weeks after intraocular lens (iol) explantation, the patient expressed dissatisfaction with the cosmetic appearance of the eye.Medical records noted increased lower-lid laxity and forniceal space associated with the globe appearing smaller and sunken.Approximately three months later, the patient underwent an evisceration procedure due to a blind and painful globe.Three months following the evisceration, the patient was fitted with an ocular prosthesis.

• 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 pl blvd; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 n park place blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22499828
• Report Number: 0001313525-2025-00148
• Device Sequence Number: 12943221
• Product Code: MFK
• UDI-Device Identifier: 10757770640178
• UDI-Public: (01)10757770640178(17)280430(11)250510(10)3R11822
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 06/17/2026

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: ETNU125+150
• Device Lot Number: 3R11822
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 05/19/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/14/2025; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCON VISCOAT, B+L INJECTOR SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male